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PMA Final Decisions Rendered for October 2001 |
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.
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
10/12/01 |
Focus® Night and Day (lotrafilcon A) Soft Contact Lenses (extended wear for 1 to 7 days) |
CIBA Vision Corporation |
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. |
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. |
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
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