Premarket Approval Decisions for October 2001

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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horizonal rule

PMA Final Decisions Rendered for October 2001

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 2002. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P000030 10/12/01	Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses (extended wear for 1 to 7 days)	CIBA Vision Corporation Duluth, GA 30097	Approval for the Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses. The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for 1 to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. Lenses should be replaced every month and when removed between replacement times must be cleaned and disinfected with a chemical, not heat disinfection system before reinsertion.
P010019 10/11/01	Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses (extended wear for up to 30 nights for continuous wear)	CIBA Vision Corporation Duluth, GA30097	Approval for the Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses for extended wear. The device will be marketed with the following trade names and indications: Focus® NIGHT & DAY™ (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism. Focus® NIGHT & DAY™ TORIC (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. Focus® NIGHT & DAY PROGRESSIVES (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P000030

10/12/01

Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses (extended wear for 1 to 7 days)

CIBA Vision Corporation
Duluth, GA
30097

Approval for the Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses. The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for 1 to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. Lenses should be replaced every month and when removed between replacement times must be cleaned and disinfected with a chemical, not heat disinfection system before reinsertion.

P010019

10/11/01

Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses (extended wear for up to 30 nights for continuous wear)

CIBA Vision Corporation Duluth, GA30097

Approval for the Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses for extended wear. The device will be marketed with the following trade names and indications: Focus® NIGHT & DAY™ (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism. Focus® NIGHT & DAY™ TORIC (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. Focus® NIGHT & DAY PROGRESSIVES (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N50510/S146 10/17/01 Special	VITEK® 2 System, Models VITEK 2 and VITEK 2 XL	BioMerieux, Inc. Hazelwood, MO 63042	Approval for a labeling change to add an instruction to the VITEK2 User's Manual which describes additional visual observation steps to the procedure for the installation of the VITEK2 Accessory kit and saline bag.
P800035/S010 10/4/01 180-Day	Peri-Oss™	Miter, Inc. Warsaw, IN 46581	Approval for a new trade name. The device, as modified, will be marketed under the trade name, Peri-Oss™ and is indicated for repair of periodontal and periapical bony defects.
P830045/S078 10/2/01 Real-Time	Integrity AFx DR with Model 3307 v2.4.1a Programmer Software	St. Jude Medical, Sylmar, CA 91342	Approval for the Model 3307 v2.4.1a Programmer Software which allows for the Integrity AFx DR Model 5342 and Integrity µ Dr Model 5336 to access the Dynamic Atrial Overdrive (DAO) and advanced hysteresis features.
P830055/S080 10/3/01 180-Day	LCS Total Knee System	DePuy Orthopaedics, Inc. Warsaw, IN 46581	Approval for a modification to the packaging components of the LCS Complete femoral components and addition of a packaging site for the metal components of the LCS Total Knee System at DePuy-Raynham, Raynham, Massachusetts.
P850020/S013 10/26/01 180-Day	Prosorba® Column	Fresenius HemoCare, Inc. Redmond, WA 98052	Approval for revised labeling that relates new post-market safety information regarding episodes of vasculitis in rheumatoid arthritis patients treated with the Prosorba® Column.
P850022/S013 10/10/01 180-Day	Biolectron OrthoPak® Bone Growth Stimulator and Biolectron SpinalPak® Fusion Stimulator	EBI, L.P. Parsippany, NJ 07054	Approval for an alternate manufacturing facility located at Electro-Biology, Inc., Guaynabo, Puerto Rico.
P870072/S013 10/31/01 180-Day	Thoratec® Ventricular Assist Device (VAD) System	Thoratec Laboratories Corporation Pleasanton, CA 94588	Approval for design changes of the tunneler used to facilitate implantation of the Thoratec VAD cannulae.
P880086/S085 10/2/01 Real-Time	Integra AFx DR with Model 3307 v2.4.1a Programmer Software	St. Jude Medical, Cardiac Sylmar, CA 91342	Approval for the Model 3307 v2.4.1a Programmer Software which allows for the Integrity AFx DR Model 5342 and Integrity µ Dr Model 5336 to access the Dynamic Atrial Overdrive (DAO) and advanced hysteresis features.
P900043/S029 10/16/01 180-Day	Bx VELOCITY™ Stent with HEPACOAT™ on RaptorRail™ Stent Delivery System	Cordis Corporation Warren, NJ 07059	Approval for the Bx VELOCITY™ Stent with HEPACOAT™ on RaptorRail™ Stent Delivery System. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (≤30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm. The 2.25 mm, 2.5 mm and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.
P900061/S047 10/10/01 Real-Time	GEM VR Models 7227 B/D/E/Cx	Medtronic, Inc. Minneapolis, MN 55432	Approval for modifications to the connector modules and connector assembly. The device, as modified, will be marketed under the trade name GEM VR Models 7227 B/D/E/Cx and is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of a cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated, sustained ventricular tachycardia.
P910001/S020 10/10/01 180-Day	CVX-300 Excimer Laser Coronary Angioplasty (ELCA) System	Spectranetics Corporation Colorado Springs, CO 80907	Approval for an additional indication, the treatment of restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy, for the CVX-300 Excimer Laser Coronary Angioplasty (ELCA) System. The indication is in addition to those listed in the February 19, 1993 approval letter.
P910023/S055 10/2/01 Real-Time	Model 3307 v2.4.1a Programmer Software	St. Jude Medical, Cardiac Sylmar, CA 91342	Approval for the Model 3307 v2.4.1a Programmer Software which allows for the Integrity AFx DR Model 5342 and Integrity µ Dr Model 5336 to access the Dynamic Atrial Overdrive (DAO) and advanced hysteresis features.
P910023/S056 10/15/01 Real-Time	Programmer Software, Model 3307 v2.5a; Programmer Software, Version 5.2E; Device Software, Firmware Version 5.3.1	St. Jude Medical Sunnyvale, CA 94086	Approval for minor updates to the device software for the Photon™ DR ICD (Model V-230HV) and the Photon™ Micro (μ) VR/DR ICDs (Models V-194/V-232) and minor updates to the programmer software supporting the Model 3500 and Model 3510 Programmers as well as the software supporting the PR-1500 and PR-3500 Model programmers.
P920032/S007 10/26/01 180-Day	Model 4170 BEDSIDE™ Single Chamber, External Pulse Generator	PACE Medical, Inc. Waltham, MA 02451	Approval for the Model 4170 BEDSIDE™ Single Chamber, External Pulse Generator. The Model 4170 is indicated for "any clinical situation in which the use of temporary pacemaker on a patient provides therapeutic or diagnostic value, or serves a prophylactic purpose. Specifically, indications for temporary pacemakers include, but are not limited to, the following: intermittent or complete heart block associated with asystole or bradycardia, symptomatic sinus bradycardia, surgically-induced heart block and heart block accompanying an acute myocardial infarction."
P930029/S015 10/9/01 Real-Time	RF CONTACTR™ Ablation Catheter Model Numbers 70246034, 70247533, 70256034 and 70257533	Medtronic, Inc. Shoreview, MN 55126	Approval for addition of a secondary distal curve feature capable of deflections of up to 135 degrees and the removal of the variable curve reach feature and other minor design changes. The device, as modified, will be marketed under the trade name RF CONTACTR™ Ablation Catheter and is indicated for use with a Medtronic RF Power Generator for the interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
P940013/S007 10/4/01 180-Day	Precision® Ultraviolet (vasurfilcon A) Hydrophilic Contact Lens for Extended Wear	CIBA Vision Corporation Duluth, GA 30097	Approval for the alternate manufacturing facilities located at CIBA Vision Corporation, Atlanta, Georgia and CIBA Vision Batam, Batam Island, Indonesia.
P950005/S010 10/5/01 180-Day	CELSIUS™ Diagnostic/Ablation Deflectable Tip Catheter	Biosense Webster Diamond Bar, CA 91765	Approval for expanding the Indications for Use. The device, as modified, will be marketed under the trade name CELSIUS™ Diagnostic/Ablation Deflectable Tip Catheter and is indicated as follows: The Biosense Webster Celsius™ Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radiofrequency generators in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.
P950009/S004 10/5/01 180-Day	AutoPap® Primary Screening System	TriPath Imaging, Inc. Redmond, WA 98052	Approval for use of the device with AutoCyte® PREP cervical cytology slides. The device, as modified, will be marketed under the trade name AutoPap® Primary Screening System and is indicated for: The AutoPap® Primary Screening System is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slides. The AutoPap® Primary Screening System identifies up to 25% of successfully processed slides as requiring no further review. The AutoPap® primary screening system also identifies at lease 15% of all successfully processed slides for a second manual review. The device is intended to be used on both conventionally-prepared and AutoCyte® PREP cervical cytology slides. For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as high risk. Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.
P950034/S018 10/4/01 Real-Time	Seprafilm® Adhesion Barrier and Procedure Pack	Genzyme Corporation Cambridge, MA 02139	Approval for an alternate product release facility at Genzyme Surgical Products, Fall River, Massachusetts.
P950037/S019 10/11/01 180-Day	Home Monitoring System, including BA03 DDDR Pulse Generator, RUC 200 Patient Device, and B-KT0.0.A Programmer Software	BIOTRONIK, Inc. Lake Oswego, OR 97053	Approval for modifications to the hardware and software, including: 1) the addition of a low-power, radiofrequency (RF) transmitter to the implantable pulse generator (IPG); 2) modification of the IPG software to permit RF transmission of patient and device data from the IPG; 3) the addition of a cell-phone-like Patient device that receives RF data transmitted by the IPG then forwards the data to a BIOTRONIK Service Center via a cellular telephone digital data transmission service; and 4) modification of the programmer software to permit programming of these new IPG capabilities. The device, as modified, will be marketed under the trade name Home Monitoring System, including model BA03 DDDR Pulse Generator, model RUC 200 Patient Device, and model B-KT0.0.A Programmer Software, and is indicated for patients with the following conditions: Rate-adaptive pacing with the BA03 DDDR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients whom demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicted for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. Additional indications include: normal sinus rhythm and normal A-V conduction in patients who intermittently need ventricular pacing support. Note: Patients with known paroxysmal atrial fibrillation/flutter may require further evaluation prior to implantation.
P950037/S020 10/10/01 180-Day	Inos²+ CLS Pulse Generator and B-K05.V.U Programmer Software	BIOTRONIK, Inc. Lake Oswego, OR 97053	Approval for pulse generator and programmer software. The device, as modified, will be marketed under the trade name Inos²+ and is indicated for the following applications: 1) Rate adaptive pacing with the Inos Pacing System is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. 2) Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. 3) Patients whom demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P950037/S022 10/26/01 Real-Time	Axios Family of Pulse Generators and the B-K0.5.S.U Programmer Software	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Axios Family of Pulse Generators and the B-K05.S.U Programmer Software. The Axios pulse generators are indicated as follows: 1) Rate-adaptive pacing with Axios pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. 2) Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. 3) Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P960004/S019 10/26/01 Real-Time	Models 6220 and 6221 Suture Sleeve Packs for ThinLine II/ FINELINE II and ThinLine II/ FINELINE II Sterox Leads	Guidant Corporation St. Paul, MN 55112	Approval to create separate accessory packs which will include the Models 6220 and 6221 Suture Sleeves.
P960009/S021 10/19/01 Special	Medtronic Activa® Tremor Control System	Medtronic, Inc. Minneapolis, MN 55421	Approval for a change to the manufacturing process to add quality control process steps to verify that the Deep Brain Stimulation Leads, Models 3387 and 3389, are manufactured to their specification.
P960016/S007 10/4/01 180-Day	Livewire TC™ Cardiac Ablation System: Bidirectional 4 mm Tip (Model Numbers: 402287, 402288, 402289, 402290, 402279, 402280, 402281, 402282, 402271, 402272, 402273 and 402274)	St. Jude Medical Minnetonka, MN 55345	Approval for a catheter with symmetrically bidirectional deflectable tip. The device, as modified, will be marketed under the trade name Livewire TC™ Cardiac Ablation System: Bidirectional 4 mm Tip and is indicated for catheter-based atrial and ventricular cardiac mapping, and when used with a compatible radiofrequency generator for: 1) interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; 2) the treatment of AV nodal re-entrant tachycardia; and 3) creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
P960040/S024 10/26/01 Real-Time	VENTAK® PRIZM™ II Automatic Implantable Cardioverter Defibrillator (AICD) Models 1860 and 1861	Guidant Corporation St. Paul, MN 55112	Approval for the minor header modification to Prizm II (models 1860 and 1861).
P960043/S029 10/9/01 180-Day	Closer™ 6 Fr. And Closer™ S 6 Fr. SMC Systems	Perclose, Inc. Redwood City, CA 94063	Approval for expanded indications for use (i.e., interventional procedures). The Closer™ and The Closer™ S 6 Fr. SMC Systems are indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 6 Fr. sheaths. The Closer™ and The Closer™ S 6 Fr. SMC Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).
P970004/S014 10/24/01 180-Day	Medtronic® Interstim® Therapy of Urinary Control (Lead Models 3092 and 3966)	Medtronic, Inc. Minneapolis, MN 55421	Approval for Lead Models 3092 and 3966 for use with the Medtronic® Interstim® Therapy for Urinary Control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments.
P970021/S005 10/19/01 180-Day	ThermaChoice Uterine Balloon Therapy System	Gynecare, A Division of Ethicon, Inc. Somerville, NJ 08876	Approval to relocate device manufacturing due to the closure of the Gynecare Menlo Park facility. Manufacturing will be performed at RELA/Colorado MEDTech, Inc, Longmont, Colorado and at Ethicon, Inc., Somervile, New Jersey.
P970031/S010 10/31/01 180-Day	Freestyle® Subcoronary Bioprosthesis, Modified Subcoronary, Model 995MS	Medtronic, Inc. Santa Ana, CA 92075	Approval for the Freestyle® Subcoronary Bioprosthesis, Modified, Subcoronary Configuration, Model 995MS, available in sizes 19 mm, 21 mm, 23 mm, 25 mm, and 27 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic valves.
P970035/S029 10/4/01 Real-Time	S7 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Approval for the S7 with Discrete Technology™ Over-the-Wire (OTW) and Rapid Exchange (RX) Coronary Stent Systems using the AV100 balloon material.
P970040/S002 10/24/01 180-Day	Achilles Insight Ultrasonometer	GE Lunar Corporation Madison, WI 53717	Approval for: 1) the addition of 2-D real time preview imaging; 2) a new receiver transducer array; 3) higher contrast color LCD graphics and imaging; and 4) an optional larger screen display.
P980008/S008 10/25/01 Real-Time	LaserScan LSX Excimer Laser System	LaserSight Technologies, Inc. Winter Park, FL 32792	Approval to increase the pulse rate of the laser from 100 to 200 Hz.
P980023/S005 10/24/01 180-Day	Terox RV 65 (Model 332 232) Terox RV 75 (Model 332 231) Kainox SL 65/13 (Model 124 235) Kainox SL 65/16 (Model 124 236) Kainox SL 65/18 (Model 124 237)	Biotronik, Inc. Lake Oswego, OR 97035	Approval for modifications to the legally marketed Kainox RV and Kainox SL Lead Systems. The device, as modified, will be marketed under the trade name Terox RV 65 (Model 332 232), Terox RV 75 (Model 332 231), Kainox SL 65/13 (Model 124 235), Kainox SL 65/16 (Model 124 236), Kainox SL 65/18 (Model 124 237), and is indicated for use with legally marketed BIOTRONIK implantable cardioverter defibrillators (ICD).
P980031/S004 10/11/01 180-Day	INTACS™ Prescription Inserts	Addition Technology, Inc. Fremont, CA 94538	Approval for 0.275 mm and 0.325 mm INTACS™ as well as for a new trade name, "INTACS™ prescription inserts."
P980035/S015 10/31/01 180-Day	Medtronic Kappa 700/600 Series Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432	Approval for alternate manufacturing, packaging and sterilization facilities at Medtronic Europe S.A., Tolochenaz, Switzerland.
P980040/S002 10/24/01 180-Day	Sensar® Soft Acrylic UV Light Absorbing Posterior Chamber Intraocular Lens (IOL)	Allergan, Inc. Irvine, CA 92623	Approval for updated anterior lens tissue ongrowth labeling.
P990009/S011 10/31/01 Real-Time	FloSeal® Matrix/Proceed™ Hemostatic Sealants	Fusion Medical Technologies, Inc. Fremont, CA 94555	Approval for an alternate kit configuration that does not contain the thrombin component.
P990014/S001 10/19/01 180-Day	Hydroview® Composite Hydrogel Foldable Ultraviolet-Absorbing Posterior Chamber Intraocular Lens (IOL)	Bausch & Lomb Surgical Claremont, CA 91711	Approval to use the Surefold 1.5 packaging for the Hydroview® IOL.
P990026/S007 10/25/01 180-Day	GlucoWatch® Automatic Glucose Biographer	Cygnus, Inc. Redwood, CA 94063	Approval for the manufacturing facility located at Cygnus, Inc., Redwood, California.
P990037/S005 10/31/01 180-Day	Vascular Solutions Duett Sealing Device, Model 1000	Vascular Solutions, Inc. Minneapolis, MN 55441	Approval for a modified catheter to be used with the Duett Model 1000 sealing device.
P990052/S006 10/26/01 180-Day	Vibrant Soundbridge™ Audio Processor Model 404 (a component of the Vibrant® Soundbridge™ System)	Symphonix Devices, Inc. San Jose, CA 95131	Approval for design changes to the Audio Processor Model 404. The device, as modified, will be marketed under the trade name Vibrant® Soundbridge™ Audio Processor Model 404SR. The indications for use for the device have not changed.
P990053/S001 10/5/01 180-Day	OxiFirst Fetal Oxygen Saturation Monitoring System	Tyco Healthcare Group, LP Mallinckrodt, Inc. Pleasanton, CA 94588	Approval for changes to the post approval study plan.
P990075/S005 10/31/01 180-Day	Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis	Mentor Corporation Santa Barbara, CA 93111	Approval for revised patient labeling that incorporates the results of the focus group study.
P990080/S001 10/16/01 Real-Time	Silicone Posterior Chamber Intraocular Lens, Model Z9000	Pharmacia & Upjohn Company Pickerington, OH 43147	Approval for a new foldable, ultraviolet light-absorbing, posterior chamber intraocular lens model. The device, as modified, will be marketed under the trade name Model Z9000 and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsifi-cation. The lens is intended to be placed in the capsular bag.
P000018/S008 10/26/01 Real-Time	Novoste™ Beta-Cath™ System	Novoste Corporation Norcross, GA 30093	Approval for modification s to the design of the sterile bag and fluid collection bag provided in the Procedure Accessory Pack.
P000018/S009 10/26/01 180-Day	Novoste™ Beta-Cath™ System	Novoste Corporation Norcross, GA 30093	Approval for the revised source seed specification (2.7 - 4.0 mCi) for the Beta-Cath™ System.
P000018/S013 10/18/01 Real-Time	Novoste™ Beta-Cath™ System	Novoste Corporation Norcross, GA 30093	Approval for a modification to the design of the Transfer Device, the addition of a Twin Transport case to the Transport System, a modification to the Source Collection Container, and a modification to the Fluid Collection Bag, of the 30 mm and 40 mm Novoste™ Beta-Cath™ Systems.
P000020/S004 10/10/01 Real-Time	Bard Stinger™ SM Ablation Catheter	C.R. Bard, Inc. Lowell, MA 01851	Approval for the addition of another ablation catheter model to the existing Stinger™ product line. The device, as modified, will be marketed under the trade name Stinger™ SM Ablation Catheter and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic stimuli.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

N50510/S146

10/17/01

Special

VITEK® 2 System, Models VITEK 2 and VITEK 2 XL

BioMerieux, Inc.

Hazelwood, MO

63042

Approval for a labeling change to add an instruction to the VITEK2 User's Manual which describes additional visual observation steps to the procedure for the installation of the VITEK2 Accessory kit and saline bag.

P800035/S010

10/4/01

180-Day

Peri-Oss™

Miter, Inc.

Warsaw, IN

46581

Approval for a new trade name. The device, as modified, will be marketed under the trade name, Peri-Oss™ and is indicated for repair of periodontal and periapical bony defects.

P830045/S078

10/2/01

Real-Time

Integrity

AFx DR with Model 3307 v2.4.1a Programmer Software

St. Jude Medical,

Sylmar, CA

91342

Approval for the Model 3307 v2.4.1a Programmer Software which allows for the Integrity AFx DR Model 5342 and Integrity µ Dr Model 5336 to access the Dynamic Atrial Overdrive (DAO) and advanced hysteresis features.

P830055/S080

10/3/01

180-Day

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for a modification to the packaging components of the LCS Complete femoral components and addition of a packaging site for the metal components of the LCS Total Knee System at DePuy-Raynham, Raynham, Massachusetts.

P850020/S013

10/26/01

180-Day

Prosorba® Column

Fresenius HemoCare, Inc.

Redmond, WA

98052

Approval for revised labeling that relates new post-market safety information regarding episodes of vasculitis in rheumatoid arthritis patients treated with the Prosorba® Column.

P850022/S013

10/10/01

180-Day

Biolectron OrthoPak® Bone Growth Stimulator and Biolectron SpinalPak® Fusion Stimulator

EBI, L.P.

Parsippany, NJ

07054

Approval for an alternate manufacturing facility located at Electro-Biology, Inc., Guaynabo, Puerto Rico.

P870072/S013

10/31/01

180-Day

Thoratec® Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval for design changes of the tunneler used to facilitate implantation of the Thoratec VAD cannulae.

P880086/S085

10/2/01

Real-Time

Integra AFx DR with Model 3307 v2.4.1a Programmer Software

St. Jude Medical, Cardiac

Sylmar, CA

91342

P900043/S029

10/16/01

180-Day

Bx VELOCITY™ Stent with HEPACOAT™ on RaptorRail™ Stent Delivery System

Cordis Corporation

Warren, NJ

07059

Approval for the Bx VELOCITY™ Stent with HEPACOAT™ on RaptorRail™ Stent Delivery System. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (≤30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm. The 2.25 mm, 2.5 mm and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.

P900061/S047

10/10/01

Real-Time

GEM VR Models 7227 B/D/E/Cx

Medtronic, Inc.

Minneapolis, MN

55432

Approval for modifications to the connector modules and connector assembly. The device, as modified, will be marketed under the trade name GEM VR Models 7227 B/D/E/Cx and is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of a cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated, sustained ventricular tachycardia.

P910001/S020

10/10/01

180-Day

CVX-300 Excimer Laser Coronary Angioplasty (ELCA) System

Spectranetics Corporation

Colorado Springs, CO

80907

Approval for an additional indication, the treatment of restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy, for the CVX-300 Excimer Laser Coronary Angioplasty (ELCA) System. The indication is in addition to those listed in the February 19, 1993 approval letter.

P910023/S055

10/2/01

Real-Time

Model 3307 v2.4.1a Programmer Software

St. Jude Medical, Cardiac

Sylmar, CA

91342

P910023/S056

10/15/01

Real-Time

Programmer Software, Model 3307 v2.5a; Programmer Software, Version 5.2E; Device Software, Firmware Version 5.3.1

St. Jude Medical

Sunnyvale, CA

94086

Approval for minor updates to the device software for the Photon™ DR ICD (Model V-230HV) and the Photon™ Micro (μ) VR/DR ICDs (Models V-194/V-232) and minor updates to the programmer software supporting the Model 3500 and Model 3510 Programmers as well as the software supporting the PR-1500 and PR-3500 Model programmers.

P920032/S007

10/26/01

180-Day

Model 4170 BEDSIDE™ Single Chamber, External Pulse Generator

PACE Medical, Inc.

Waltham, MA

02451

Approval for the Model 4170 BEDSIDE™ Single Chamber, External Pulse Generator. The Model 4170 is indicated for "any clinical situation in which the use of temporary pacemaker on a patient provides therapeutic or diagnostic value, or serves a prophylactic purpose. Specifically, indications for temporary pacemakers include, but are not limited to, the following: intermittent or complete heart block associated with asystole or bradycardia, symptomatic sinus bradycardia, surgically-induced heart block and heart block accompanying an acute myocardial infarction."

P930029/S015

10/9/01

Real-Time

RF CONTACTR™ Ablation Catheter Model Numbers 70246034, 70247533, 70256034 and 70257533

Medtronic, Inc.

Shoreview, MN

55126

Approval for addition of a secondary distal curve feature capable of deflections of up to 135 degrees and the removal of the variable curve reach feature and other minor design changes. The device, as modified, will be marketed under the trade name RF CONTACTR™ Ablation Catheter and is indicated for use with a Medtronic RF Power Generator for the interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

P940013/S007

10/4/01

180-Day

Precision® Ultraviolet (vasurfilcon A) Hydrophilic Contact Lens for Extended Wear

CIBA Vision Corporation

Duluth, GA

30097

Approval for the alternate manufacturing facilities located at CIBA Vision Corporation, Atlanta, Georgia and CIBA Vision Batam, Batam Island, Indonesia.

P950005/S010

10/5/01

180-Day

CELSIUS™ Diagnostic/Ablation Deflectable Tip Catheter

Biosense Webster

Diamond Bar, CA

91765

Approval for expanding the Indications for Use. The device, as modified, will be marketed under the trade name CELSIUS™ Diagnostic/Ablation Deflectable Tip Catheter and is indicated as follows: The Biosense Webster Celsius™ Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radiofrequency generators in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.

P950009/S004

10/5/01

180-Day

AutoPap® Primary Screening System

TriPath Imaging, Inc.

Redmond, WA

98052

Approval for use of the device with AutoCyte® PREP cervical cytology slides. The device, as modified, will be marketed under the trade name AutoPap® Primary Screening System and is indicated for: The

AutoPap® Primary Screening System is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slides. The AutoPap® Primary Screening System identifies up to 25% of successfully processed slides as requiring no further review. The AutoPap® primary screening system also identifies at lease 15% of all successfully processed slides for a second manual review. The device is intended to be used on both conventionally-prepared and AutoCyte® PREP cervical cytology slides. For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as high risk. Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.

P950034/S018

10/4/01

Real-Time

Seprafilm® Adhesion Barrier and Procedure Pack

Genzyme Corporation

Cambridge, MA

02139

Approval for an alternate product release facility at Genzyme Surgical Products, Fall River, Massachusetts.

P950037/S019

10/11/01

180-Day

Home Monitoring System, including BA03 DDDR Pulse Generator, RUC 200 Patient Device, and B-KT0.0.A Programmer Software

BIOTRONIK, Inc.

Lake Oswego, OR

97053

Approval for modifications to the hardware and software, including: 1) the addition of a low-power, radiofrequency (RF) transmitter to the implantable pulse generator (IPG); 2) modification of the IPG software to permit RF transmission of patient and device data from the IPG; 3) the addition of a cell-phone-like Patient device that receives RF data transmitted by the IPG then forwards the data to a BIOTRONIK Service Center via a cellular telephone digital data transmission service; and 4) modification of the programmer software to permit programming of these new IPG capabilities. The device, as modified, will be marketed under the trade name Home Monitoring System, including model BA03 DDDR Pulse Generator, model RUC 200 Patient Device, and model B-KT0.0.A Programmer Software, and is indicated for patients with the following conditions: Rate-adaptive pacing with the BA03 DDDR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients whom demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicted for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. Additional indications include: normal sinus rhythm and normal A-V conduction in patients who intermittently need ventricular pacing support. Note: Patients with known paroxysmal atrial fibrillation/flutter may require further evaluation prior to implantation.

P950037/S020

10/10/01

180-Day

Inos²+ CLS Pulse Generator and B-K05.V.U Programmer Software

BIOTRONIK, Inc.

Lake Oswego, OR

97053

Approval for pulse generator and programmer software. The device, as modified, will be marketed under the trade name Inos²+ and is indicated for the following applications: 1) Rate adaptive pacing with the Inos Pacing System is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. 2) Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. 3) Patients whom demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.

P950037/S022

10/26/01

Real-Time

Axios Family of Pulse Generators and the B-K0.5.S.U Programmer Software

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Axios Family of Pulse Generators and the B-K05.S.U Programmer Software. The Axios pulse generators are indicated as follows: 1) Rate-adaptive pacing with Axios pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. 2) Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. 3) Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.

P960004/S019

10/26/01

Real-Time

Models 6220 and 6221 Suture Sleeve Packs for ThinLine II/ FINELINE II and ThinLine II/ FINELINE II Sterox Leads

Guidant Corporation

St. Paul, MN

55112

Approval to create separate accessory packs which will include the Models 6220 and 6221 Suture Sleeves.

P960009/S021

10/19/01

Special

Medtronic Activa® Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the manufacturing process to add quality control process steps to verify that the Deep Brain Stimulation Leads, Models 3387 and 3389, are manufactured to their specification.

P960016/S007

10/4/01

180-Day

Livewire TC™ Cardiac Ablation System: Bidirectional 4 mm Tip (Model Numbers: 402287, 402288, 402289, 402290, 402279, 402280, 402281, 402282, 402271, 402272, 402273 and 402274)

St. Jude Medical

Minnetonka, MN

55345

Approval for a catheter with symmetrically bidirectional deflectable tip. The device, as modified, will be marketed under the trade name Livewire TC™ Cardiac Ablation System: Bidirectional 4 mm Tip and is indicated for catheter-based atrial and ventricular cardiac mapping, and when used with a compatible radiofrequency generator for: 1) interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; 2) the treatment of AV nodal re-entrant tachycardia; and 3) creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.

P960040/S024

10/26/01

Real-Time

VENTAK® PRIZM™ II Automatic Implantable Cardioverter Defibrillator (AICD) Models 1860 and 1861

Guidant Corporation

St. Paul, MN

55112

Approval for the minor header modification to Prizm II (models 1860 and 1861).

P960043/S029

10/9/01

180-Day

Closer™ 6 Fr. And Closer™ S 6 Fr. SMC Systems

Perclose, Inc.

Redwood City, CA

94063

Approval for expanded indications for use (i.e., interventional procedures). The Closer™ and The Closer™ S 6 Fr. SMC Systems are indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 6 Fr. sheaths. The Closer™ and The Closer™ S 6 Fr. SMC Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).

P970004/S014

10/24/01

180-Day

Medtronic® Interstim® Therapy of Urinary Control (Lead Models 3092 and 3966)

Medtronic, Inc.

Minneapolis, MN

55421

Approval for Lead Models 3092 and 3966 for use with the Medtronic® Interstim® Therapy for Urinary Control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments.

P970021/S005

10/19/01

180-Day

ThermaChoice Uterine Balloon Therapy System

Gynecare, A Division of

Ethicon, Inc.

Somerville, NJ

08876

Approval to relocate device manufacturing due to the closure of the Gynecare Menlo Park facility. Manufacturing will be performed at RELA/Colorado MEDTech, Inc, Longmont, Colorado and at Ethicon, Inc., Somervile, New Jersey.

P970031/S010

10/31/01

180-Day

Freestyle® Subcoronary Bioprosthesis, Modified Subcoronary, Model 995MS

Medtronic, Inc.

Santa Ana, CA

92075

Approval for the Freestyle® Subcoronary Bioprosthesis, Modified, Subcoronary Configuration, Model 995MS, available in sizes 19 mm, 21 mm, 23 mm, 25 mm, and 27 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic valves.

P970035/S029

10/4/01

Real-Time

S7 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for the S7 with Discrete Technology™ Over-the-Wire (OTW) and Rapid Exchange (RX) Coronary Stent Systems using the AV100 balloon material.

P970040/S002

10/24/01

180-Day

Achilles Insight Ultrasonometer

GE Lunar Corporation

Madison, WI

53717

Approval for: 1) the addition of 2-D real time preview imaging; 2) a new receiver transducer array; 3) higher contrast color LCD graphics and imaging; and 4) an optional larger screen display.

P980008/S008

10/25/01

Real-Time

LaserScan LSX Excimer Laser System

LaserSight Technologies, Inc.

Winter Park, FL

32792

Approval to increase the pulse rate of the laser from 100 to 200 Hz.

P980023/S005

10/24/01

180-Day

Terox RV 65 (Model 332 232) Terox RV 75 (Model 332 231)

Kainox SL 65/13 (Model 124 235)

Kainox SL 65/16 (Model 124 236) Kainox SL 65/18 (Model 124 237)

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for modifications to the legally marketed Kainox RV and Kainox SL Lead Systems. The device, as modified, will be marketed under the trade name Terox RV 65 (Model 332 232), Terox RV 75 (Model 332 231),

Kainox SL 65/13 (Model 124 235),

Kainox SL 65/16 (Model 124 236), Kainox SL 65/18 (Model 124 237), and is indicated for use with legally marketed BIOTRONIK implantable cardioverter defibrillators (ICD).

P980031/S004

10/11/01

180-Day

INTACS™ Prescription Inserts

Addition Technology, Inc.

Fremont, CA

94538

Approval for 0.275 mm and 0.325 mm INTACS™ as well as for a new trade name, "INTACS™ prescription inserts."

P980035/S015

10/31/01

180-Day

Medtronic Kappa 700/600 Series Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for alternate manufacturing, packaging and sterilization facilities at Medtronic Europe S.A., Tolochenaz, Switzerland.

P980040/S002

10/24/01

180-Day

Sensar® Soft Acrylic UV Light Absorbing Posterior Chamber Intraocular Lens (IOL)

Allergan, Inc.

Irvine, CA

92623

Approval for updated anterior lens tissue ongrowth labeling.

P990009/S011

10/31/01

Real-Time

FloSeal® Matrix/Proceed™ Hemostatic Sealants

Fusion Medical Technologies, Inc.

Fremont, CA

94555

Approval for an alternate kit configuration that does not contain the thrombin component.

P990014/S001

10/19/01

180-Day

Hydroview® Composite Hydrogel Foldable Ultraviolet-Absorbing Posterior Chamber Intraocular Lens (IOL)

Bausch & Lomb Surgical

Claremont, CA

91711

Approval to use the Surefold 1.5 packaging for the Hydroview® IOL.

P990026/S007

10/25/01

180-Day

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood, CA

94063

Approval for the manufacturing facility located at Cygnus, Inc., Redwood, California.

P990037/S005

10/31/01

180-Day

Vascular Solutions Duett Sealing Device, Model 1000

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for a modified catheter to be used with the Duett Model 1000 sealing device.

P990052/S006

10/26/01

180-Day

Vibrant Soundbridge™ Audio Processor Model 404 (a component of the Vibrant® Soundbridge™ System)

Symphonix Devices, Inc.

San Jose, CA

95131

Approval for design changes to the Audio Processor Model 404. The device, as modified, will be marketed under the trade name Vibrant® Soundbridge™ Audio Processor Model 404SR. The indications for use for the device have not changed.

P990053/S001

10/5/01

180-Day

OxiFirst Fetal Oxygen Saturation Monitoring System

Tyco Healthcare Group, LP

Mallinckrodt, Inc.

Pleasanton, CA

94588

Approval for changes to the post approval study plan.

P990075/S005

10/31/01

180-Day

Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis

Mentor Corporation

Santa Barbara, CA

93111

Approval for revised patient labeling that incorporates the results of the focus group study.

P990080/S001

10/16/01

Real-Time

Silicone Posterior Chamber Intraocular Lens, Model Z9000

Pharmacia & Upjohn Company

Pickerington, OH

43147

Approval for a new foldable, ultraviolet light-absorbing, posterior chamber intraocular lens model. The device, as modified, will be marketed under the trade name Model Z9000 and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsifi-cation. The lens is intended to be placed in the capsular bag.

P000018/S008

10/26/01

Real-Time

Novoste™

Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for modification s to the design of the sterile bag and fluid collection bag provided in the Procedure Accessory Pack.

P000018/S009

10/26/01

180-Day

Novoste™

Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for the revised source seed specification (2.7 - 4.0 mCi) for the Beta-Cath™ System.

P000018/S013

10/18/01

Real-Time

Novoste™

Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for a modification to the design of the Transfer Device, the addition of a Twin Transport case to the Transport System, a modification to the Source Collection Container, and a modification to the Fluid Collection Bag, of the 30 mm and 40 mm Novoste™ Beta-Cath™ Systems.

P000020/S004

10/10/01

Real-Time

Bard Stinger™ SM Ablation Catheter

C.R. Bard, Inc.

Lowell, MA

01851

Approval for the addition of another ablation catheter model to the existing Stinger™ product line. The device, as modified, will be marketed under the trade name Stinger™ SM Ablation Catheter and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic stimuli.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P880006/S034 10/25/01	Regency SC+ 2402L Pulse Generators	St. Jude Medical Sylmar, CA 91342	Elimination of the in-process x-ray imaging of the Regency SC+ Pulse Generators.
P900052/S009 10/1/01	PORT-A-CATH® Epidural Implantable Access System and PORT-A-CATH(®II Epidural Low Profile™ Implantable Access System	Deltec, Inc. St. Paul, MN 55112	Eliminate the inspection procedure on some incoming components used in the manufacture of the PORT-A-CATH® Epidural Systems.
P900061/S048 10/24/01	Gem Implantable Cardioverter Defibrillators	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.
P930038/S032 10/2/01	Angio-Seal™ Vascular Closure Device	St. Jude Medical, Minnetonka, MN 55345	St. Jude to manufacture the 8F arterial anchors in-house.
P970012/S011 10/24/01	Kappa 400 Implantable Pulse Generator	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.
P970013/S002 10/25/01	Microny 2425T, 2525T and 2535K Pulse Generators	St. Jude Medical Sylmar, CA 91342	Elimination of the in-process x-ray imaging of the Microny Pulse Generators.
P970035/S030 10/2/01	S7, S670 and S660 with Discrete Technology™ Rapid Exchange Coronary Stent System	Medtronic AVE Santa Rose, CA 95403	Change in the manufacturing process of joining the two types of tubing to a process where the jacket is extruded directly onto the hypotube.
P980016/S022 10/24/01	Gem DR, Gem II VR, Gem II DR, and Gem III Implantable Cardioverter Defibrillators	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.
P980035/S012 10/24/01	Kappa 700/600 Series, Medtronic 350 Series, Sigma Series Implantable Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.
P980050/S009 10/24/01	Gem III AT and Jewel AF Implantable Cardioverter Defibrillators	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.
P990001/S008 10/24/01	Dema and Diva Implantable Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.
P990066/S006 10/1/01	GE Medical System's Senographe 2000D Full Field Digital Mammography System	GE Medical System Milwaukee, WI 53201	Addition of a supplier for the column mounted on the Senographe 2000D System. There will be no impact on the manufacturing processes (assembly and testing). There are no labeling changes or design changes to the specifications of the finished device.
P000010/S001 10/12/01	AMPLICOR® HCV Test, v2.0	Roche Molecular Systems, Inc. Pleasanton, CA 94566	Change in quality control specifications.
P000011/S005 10/22/01	BiodivYsio AS OTW	Biocompatibles Cardiovascular, Inc. San Jose, CA 95113	Amending existing procedures to improve the inspection of stents after laser cutting, prior to and after electropolishing; and addition of the Universal Stent Crimper.
P000012/S001 10/12/01	COBAS AMPLICOR™ HCV Test, v2.0	Roche Molecular Systems, Inc. Pleasanton, CA 94566	Change in quality control specifications.
P000022/S008 10/2/01	BeStent™ 2 with Discrete Technology™ Rapid Exchange Coronary Stent Delivery System	Medtronic AVE Santa Rose, CA 95403	Change in the manufacturing process of joining the two types of tubing to a process where the jacket is extruded directly onto the hypotube.
P010015/S001 10/24/01	InSync Implantable Pulse Generators, Model 8040	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment.

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 49

Summary of PMA Originals Under Review

Total Under Review: 81

Total Active: 47

Total On Hold: 34

Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review

Total Under Review: 237

Total Active: 142

Total On Hold: 95

Number Greater Than 180 Days: 4

Summary of All PMA Submissions Received

Originals: 3

Supplements: 65

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 49

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 149.2

FDA Time: 112.6 Days MFR Time: 36.6 Days

Updated 11/7/2001

horizonal rule

Center for Devices and Radiological Health / CDRH