FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Final Decisions Rendered for March 2003 |
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. This list is generated on a monthly basis.
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
3/14/03 |
NeedleZap™ |
E Med Future, Inc. Columbus, OH 43230 |
Approval for the NeedleZap. The device is a portable needle destruction device that is indicated for use by health care professionals to destroy previously used aluminum and stainless steel needles (gauges 16 - 30, ¾ - 2 inches in length) attached to syringes. The NeedleZap product is intended for use in health care facilities and treatment settings. |
3/28/03 |
Bayer Versant™ HCV RNA 3.0 Assay (bDNA) |
Bayer Diagnostics Berkeley, CA 94702 |
Approval for the Bayer Versant HCV RNA 3.0 Assay (bDNA). The device is indicated for: The VERSANT HCV RNA 3.0 Assay (bDNA) is a signal amplification nucleic acid probe assay for the quantitation of human hepatitis C viral RNA (HCV RNA) in the serum or plasma (EDTA and ACD) of HCV-infected individuals using the Bayer System 340 bDNA Analyzer. Specimens containing HCV genotypes 1-6 have been validated for quantitation in the assay. The VERSANT HCV RNA 3.0 Assay is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and are useful in predicting non-response to HCV therapy, and are predictive of non-sustained virological response. The results from the VERSANT HCV RNA 3.0 Assay (bDNA) must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established only for individuals treated with interferon alfa-2b plus ribavirin. No information is available on the assay predictive values when other therapies are used. |
3/28/03 |
FemCap™ Barrier Contraceptive |
FemCap, Inc. Del Mar, CA 92014 |
Approval for the FemCap™ Barrier Contraceptive. The FemCap™ is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy. |
P790017/S079 3/4/03 Real-Time |
NC Stormer Over-The-Wire Balloon Dilatation Catheter and NC Stormer Zipper MX Balloon Dilatation Catheter |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Approval to make modifications to the Stormer Balloon Dilatation Catheter with Zipper Delivery. The devices, as modified, will be marketed under the trade names NC Stormer Over-The-Wire Balloon Dilatation Catheter and NC Stormer Zipper MX Balloon Dilatation Catheter and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The NC Stormer balloon dilatation catheter (balloon models 2.5 mm – 4.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. NOTE: bench testing was conducted with the NC Stormer balloon dilatation catheter and marketed balloon expandable stents. Consideration would be taken when the device is used with different manufacturers’ stents due to differences in stent design. |
3/11/03 Panel |
CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen |
Inamed Corporation Santa Barbara, CA 93111 |
Approval for CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen. The indications for use are as follows: CosmoDerm™ 1 Human-Based Collagen and CosmoDerm™ 2 Human-Based Collagen are injected into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars, and CosmoPlast™ Human-Based Collagen is injected into the mid to deep dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars. |
P820060/S017 3/5/03 Special |
AFP Control Pack |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for initiating heat stress reference testing for the Plasma Diagnostic Base (PDB; control diluent) used in the preparation of the controls for the AFP assays. |
P830037/S048 3/6/03 Real-Time |
FreshLook® Dimensions™ (phemfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear up to 7 days/6 nights (Spherical and Toric with or without UV absorber; Cast-molded) |
CIBA Vision Corporation Duluth, CA 30097 |
Approval for the FreshLook® Dimensions™ (phemfilcon A) Soft (hydrophilic) Contact Lens indicated for extended wear up to 6 nights/7 days. This device will be an optimized combination of two of the previously approved processes; namely, current FreshLook® ColorBlends (multiple print) Printing Process (P830037/S045) and the FreshLook® Handling Tint Monomer Tinting Process (830037/S039). This additional process of printing onto a tinted lens for the FreshLook® (phemfilcon A) Soft (hydrophilic) Contact Lens family offers the patient a contact lens option with a better contrast in the printed portion of the lens. The device, as modified, will be marketed under the FreshLook® trade name with the following indication: FreshLook® Dimensions™ (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens acts to enhance or alter the apparent color of the eye. FreshLook® Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens acts to enhance or alter the apparent color of the eye. The lenses may be prescribed for extended wear in not-aphakic persons from 1-7 days between removal for cleaning and disinfection or disposal, as recommended by the eye care practitioner. The eye care practitioner may prescribe the lens in either a single use disposable program or in a frequent replacement program with cleaning, disinfection, and scheduled replacement. When prescribed in a frequent replacement program, the lens may be disinfected using a chemical disinfection system. FreshLook® Soft Contact Lenses with UV absorbing monomer help protect against transmission of harmful UV radiation to the cornea and into the eye. |
P830045/S085 3/20/03 Real-Time |
Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a. These devices are indicated as follows: Implantation of Identity ADx Models 5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation and severe physical disability. AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. |
P850048/S019 3/3/03 Real-Time |
Access Hybritech® PSA on the UniCel™ DxI 800 Access® Immunoassay System |
Beckman Coulter, Inc. Chaska, MN 55318 |
Approval to add the Access Hybritech PSA Assay to the UniCel™ DxI 800 Access Immunoassay System. |
P860026/S008 3/3/03 180-Day |
Diaphragmatic Pacemaker Phrenic Nerve Stimulator |
Avery Laboratories, Inc. Commack, NY 11725 |
Approval for selecting a final value of C22 and C50 capacitors during production testing based on parameters measured with calibrated test equipment to result in peak operating performance of the transmitter. |
P880086/S093 3/20/03 Real-Time |
Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a. These devices are indicated as follows: Implantation of Identity ADx Models 5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation and severe physical disability. AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. |
3/31/03 Panel |
Digene Hybrid Capture® 2 (HC2) High-Risk HPV DNA Test |
Digene Corporation Gaithersburg, MD 20878 |
Approval for the Digene Hybrid Capture® 2 (HC2) High-Risk HPV DNA Test. The device is indicated for: 1) To screen patients with ASCUS (atypical squamous cells of undetermined significance) Pap smear results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy. 2) In women 30 years and older the HC2 High-Risk HPV DNA Test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. |
P910018/S007 3/6/03 180-Day |
Liposorber® LA-15 System |
Kaneka Pharma America Medical Corporation New York, NY 10022 |
Approval for the transfer of the assembly and soldering of printed circuit boards used in conjunction with the final assembly of the MA-01 Apheresis Machine to Yokogawa Ibiden Components Corporaiton, Oume-City, Tokyo 198 JAPAN. |
P910023/S066 3/20/03 Real-Time |
Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a. These devices are indicated as follows: Implantation of Identity ADx Models 5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation and severe physical disability. AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. |
P910077/S039 3/21/03 180-Day |
Ventak PRx and MINI ICDs |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the patient handbooks. |
P920014/S020 3/21/03 Special |
Thoratec® HeartMate® Stroke Volume Limiter |
Thoratec Corporation Pleasanton, CA 94588 |
Approval for specific additional safety instructions to the labeling for the Stroke Volume Limiter. |
P930021/S006 3/28/03 180-Day |
Emdogain™ Gel |
Biora, Inc. Chicago, IL 60610 |
Approval for extension of the expiration date on Emdogain® Gel from 18 months to 24 months. |
P930029/S020 3/3/03 Real-Time |
Medtronic Atakr II Model 4802 (60W) Software Version 1.36 |
Medtronic EP Systems Minneapolis, MN 55432 |
Approval for a software upgrade (version 1.36) for the Medtronic Atakr II Model 4802 (60SW) radio frequency generator. |
P940015/S009 3/14/03 Special |
Synvisc® (hylan G-F 20) |
Genzyme Biosurgery Cambridge, MA 02139 |
Approval for the addition of the following precaution statement to the Synvisc® Physician Package Insert: “Twist the gray tip cap before pulling it off, as this will minimize product leakage”. |
P940031/S027 3/21/03 180-Day |
Vigor DR/SR and Discovery Meridian AR |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the patient handbooks. |
P950018/S009 3/20/03 Real-Time |
Perfluoron™ |
Alcon Laboratories Fort Worth, TX 76134 |
Approval for a new stability protocol that will extend the expiration dating for Perfluoron from 2 years to up to 4 years for the currently approved product configuration, with stability testing data reported via annual reports in the future. |
P950020/S006 3/11/03 180-Day |
Cutting Balloon™ |
Boston Scientific – Interventional Technologies San Diego, CA 92123 |
Approval for: 1) use of the Bioslide™ coating on all Cutting Balloon™ models, and 2) use of a revised Y-site on Over-the-Wire (OTW) Cutting Balloon™ models. The device, as modified, will be marketed under the trade name Cutting Balloon™ Monorail/OTW and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should posses the following characteristics: discrete (≤ 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (< 45 º), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification. |
P950022/S016 3/25/03 Real-Time |
Riata Defibrillation Lead System Model 1572 and 1582 |
St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for single defibrillation coil lead models 1572 and 1582. |
P950039/S010 3/27/03 Special |
ThinPep® 2000 System and ThinPrep® 3000 Processor: PreservCyt Solution, Alternative Transport Medium for Roche Diagnostics COBAS AMPLICOR CT/NG Test. |
Cytyc Corporation Boxborough, MA 01719 |
Approval for labeling changes for the PreservCyt Solution as an Alternative Transport Medium for Roche Diagnostics COBAS AMPLICOR CT/NG Test. |
P960016/S009 3/28/03 Real-Time |
Livewire TC™ Cardiac Ablation System |
St. Jude Medical Minnetonka, MN 55345 |
Approval for revised indications for use for these models of Livewire TC™ ablation catheters: 5mm Livewire TC™ Steerable Electrophysiology Catheters XLS With Universal Sensor (Models 402205-402208); 5mm Livewire TC™ Steerable Electrophysiology Catheters XLS With Thermistor (Models 402209-402212); 5mm Livewire TC™ Steerable Electrophysiology Catheters XLS with Thermocouple (Models 402213-402216); 4mm Livewire TC™ Steerable Electrophysiology Cathether With Thermistor (Models 402229-402232); and 4mm Livewire TC™ Steerable Electrophysiology Catheter XLS with Thermistor (Models 402233-402236). The catheters are indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. |
3/27/03 Panel |
VENTAK PRIZM® AVT™ AICD System Model 1900; Programmer Software Application Model 2849 Version 2.4; PERIMETER™ CS Coronary Sinus Defibrillation Lead Models 0202, 0203, and 0204; Stylet Accessory Kits Models 6321, 6322, 6323, 6324, 6325, 6326, 6327, 6328, and 6329; and PARTNER™ Rhythm Assistant Model 2930 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the VANTAK PRIZM AVT® AICD System. The device is indicated for use in the following: Patients who are ICD indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias. Patient populations who are indicated for a Guidant ICD include: 1) those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction ≤30% (as defined in the MADIT II Clinical Study appendix). |
P960040/S029 3/26/03 180-Day |
Vitality™ AVT™ and the Programmer Software Application Model 2812 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the addition of atrial arrhythmia therapies to the Vitality™ AICD System. The device, as modified, will be marketed under the trade name Vitality™ AVT™ and Programmer Software Application Model 2812, and is indicated for use in the following: Patients who are ICD indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias. Patient populations who are indicated for a Guidant ICD include: 1) those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction ≤30% (as defined in the MADIT II Clinical Study appendix). |
P960040/S030 3/21/03 180-Day |
Ventak AV and Ventak Prizm DR/VR AICDs |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the patient handbooks. |
D970003/S019 3/21/03 180-Day |
PULSAR MAX |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the patient handbooks. |
P970021/S007 3/27/03 180-Day |
Gynecare Thermachoice Uterine Balloon Therapy System |
Gynecare, a division of Ethicon, Inc. Somerville, NJ 08876 |
Approval for a new manufacturing site located at Colorado MEDtech, Inc., Boulder, Colorado. The Gynecare Thermachoice Controller will be manufactured at this facility. |
P970058/S015 3/4/03 180-Day |
ImageChecker |
R2 Technologies, Inc. Sunnyvale, CA 94087 |
Approval for a new manufacturing facility located at R2 Technologies, Inc. Sunnyvale, California. |
P980016/S031 3/6/03 180-Day |
Model 7230 Marquis VR Single Chamber ICD System |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a move of the European Operations Center from Kerkrade, The Netherlands to Medtronic B.V., Heerleen, The Netherlands. |
3/26/03 180-Day |
Medtronic AT500 DDDRP Pacing System (Model AT501) and Model 9968 Software |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic AT500 DDDRP Pacing System (Model AT501) and Model 9968 Software. The Medtronic AT500 DDDRP Pacing System is indicated for the following: 1) Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. 2) Accepted patient conditions warranting chronic cardiac pacing which include: a)Symptomatic paroxysmal or permanent second or third-degree AV block. b) Symptomatic bilateral bundle branch block. c) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders. d) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. The Medtronic AT500 system is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output. 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. Antitachycardia Pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications. Atrial rhythm management features such as Atrial Rate Stabilization (ARS) Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications. |
P990015/S002 3/18/03 180-Day |
GYNECARE INTERGEL Adhesion Prevention Solution |
Lifecore Biomedical, Inc. Chaska, MN 55318 |
Approval for changes to the labeling in response to adverse event reports of additional surgery, including hysterectomy, that occurred following post-operative pain, ascites, non-infectious peritonitis, and/or possible delayed clearance of GYNECARE INTERGEL. |
P990037/S014 3/14/03 Special |
Vascular Solutions Duett™ sealing device |
Vascular Solutions, Inc. Minneapolis, MN 55441 |
Approval for an additional incoming inspection requirement to measure the Outer Diameter (OD) of the distal end of the stopcock and to tighten the tolerance around the originally approved OD on the stopcock distal end. |
P990038/S004 3/14/03 180-Day |
DiaSorin HBsAg Confirmatory Test |
DiaSorin, Inc. Saluggia, Italy |
Approval for use of a DiaSorin HBsAg confirmatory reagent to confirm ETI-MAK-2 PLUS repeatedly reactive samples, and use of a DiaSorin confirmatory reagent specifically in prenatal screening to confirm all ETI-MAK-2 PLUS repeatedly reactive samples in the absence of other HBV marker testing. The device, as modified, will be marketed under the trade name DiaSorin HBsAg Confirmatory Test and is indicated for an in vitro neutralization assay for qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma samples (EDTA, heparin, and citrate) found to be repeatedly reactive for HBsAg by ETI-MAK-2 PLUS. This assay has not been FDA-approved for the screening of blood or plasma donors. |
P990074/S014 3/12/03 180-Day |
McGhan Saline-Filled Breast Implants |
Inamed Corporation Santa Barbara, CA 93111 |
Approval to manufacture McGhan Saline-Filled Breast Implants, Styles 168, 163, 363LF, and 468 at Inamed Corporation’s facility located in Barreal de Heredia, Costa Rica. |
3/14/03 Panel |
Healthtronics OssaTron® |
Healthtronics Surgical Services, Inc. Marietta, GA 30062 |
Approval for the Healthtronics OssaTron®. The device is indicated for use for performing extracorporeal shock wave (ESW) treatment in patients with chronic lateral epicondylitis (tennis elbow) that has failed to respond to conservative treatment. Chronic Lateral Epicondylitis is defined as lateral epicondylitis that has persisted for 6 months or more with a history of unsuccessful conservative treatment. |
P000013/S001 3/17/03 Real-Time |
Osteonics ABC/Trident Systems |
Howmedica Osteonics Corporation Allendale, NJ 07401 |
Approval for the following items: 1) Use of the Trident Acetabular System with V40 Alumina Heads and additional C-Taper Alumina Head sizes (and associated stems) 2) Use of the Trident Acetabular System with V40/C-Taper and Morse Taper Adapter Sleeves (and associated femoral stems) 3) Use of additional styles of Trident Acetabular Shells; and 4) Associated labeling changes due to modifications identified above. |
P000018/S031 3/17/03 Special |
Novoste™ Beta-Cath™ 3.5 System |
Novoste Corp. Norcross, GA 30093 |
Approval for an additional inspection step in the manufacturing process of the β-Rail™ 3.5F Delivery Catheter. |
P000025/S006 3/18/03 180-Day |
MED-EL COMBI 40+ Cochlear Implant System with C40+, C40+S, or C40+GB Implants, and CIS PRP+/TEMPO+ Speech Processors |
MED-EL Corporation Durham, NC 27713 |
Approval for broadening the indication of the C40+ Cochlear Implant System to include children aged twelve months or older. |
P000025/S008 3/25/03 Special |
MED-EL COMBI 40+ Cochlear Implant System; MED-EL COMBI 40+ (Standard), COMBI 40+S (Compressed), and COMBI 40+ GB (Split) Cochlear Implant Electrode Arrays; Tempo+ and CIS-PRO+ Speech Processors |
MED-EL Corporation Durham, NC 27713 |
Approval for the following changes in the labeling: 1) Informational statements regarding meningitis, the use of prophylactic antibiotics, and vaccinations 2) Informational statements regarding electrostatic discharge (ESD) preventions. |
P000043/S005 3/19/03 180-Day |
TMx-2000 BPH Thermotherapy System |
TherMatrx, Inc. Northbrook, IL 60062 |
Approval to change the manufacturing site for the final product acceptance for the Rx-200 treatment catheter to Manufacturing and Research, Inc., Tucson, Arizona. |
P000046/S006 3/18/03 180-Day |
Staarvisc™ II, Shellgel™ and CoEase™ Sodium Hyaluronate Viscoelastics |
Anika Therapeutics Woburn, MA 01801 |
Approval for an additional method for endotoxin testing. |
P000046/S007 3/12/03 180-Day |
Staarvisc™ II, Shellgel™, and CoEase™ Sodium Hyaluronate Viscoelastics |
Anika Therapeutics Woburn, MA 01801 |
Approval for use of an alternate raw material source. |
P010012/S007 3/21/03 180-Day |
CONTAK CD |
Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the patient handbooks. |
P010012/S009 3/25/03 Real-Time |
EASYTRAK 3 Pacing Lead |
Guidant Corporation St. Paul, MN 55112 |
Approval for Titanium Oxide-impregnated suture sleeve and is indicated for use with Guidant EASYTRAK leads. |
P010015/S009 3/27/03 180-Day |
InSync III Model 8042 Atrial Synchronous Biventricular Pacing Device |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Medtronic B.V., European Operations Center, Heerlen, The Netherlands. Final device packaging will be performed at this facility. |
P010019/S002 3/19/03 Real-Time |
NIGHT & DAY™ 30 Night Extended Wear Soft Contact Lens |
CIBA Vision Corporation Duluth, GA 30097 |
Approval for the following indication: NIGHT & DAY™ soft contact lenses are also indicated for therapeutic use. Use as a bandage to protect the cornea and to relieve corneal pain during the treatment of acute or chronic ocular pathologies such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. NIGHT & DAY™ soft contact lenses for therapeutic use can also provide optical correction during healing if required. |
P010022/S002 3/18/03 Special |
CoSeal™ Surgical Sealant |
Cohesion Technologies, Inc. Palo Alto, CA 94303 |
Approval for a labeling change to add a boxed warning regarding swell volumes of the sealant. |
P010031/S003 3/27/03 180-Day |
Medtronic® InSync Marquis™ Model 7277 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and InSync Marquis™ Application Software Model 9983 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic InSync Marquis Model 7277 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and InSync Marquis Application Software Model 9983 and for the system to be manufactured at Med Rel, Humacaco, Puerto, Rico, Medtronic, Europe S.A, Tolochenaz, Switzerland and Medtronic BV, Kerkrade, The Netherlands. |
P010032/S007 3/5/03 180-Day |
Rapid Programmer |
Advanced Neuromodulation Systems, Inc. Plano, TX 75024 |
Approval for the Rapid Programmer which is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
P010033/S003 3/17/03 Special |
QuantiFERON-TB |
Cellestis, Inc. Valencia, CA 91355 |
Approval for labeling changes to the Instructions for Use that enhance the safe use of the QuantiFERON-TB by incorporating recommendations from the “CDC Guidelines for using the QuantiFERON-TB Test for Diagnosing Latent Mycobacterium tuberculosis Infection” (MMWR Dispatch, Vol. 51/December 18, 2002). |
P010034/S002 3/7/03 180-Day |
Second Look Computer-Aided Detection System |
CADX Medical Systems, Inc. Northborough, England |
Approval for a manufacturing site located at Colorado Medtech, Inc., Boulder, Colorado. |
P010038/S003 3/6/03 180-Day |
iCAD |
iCAD, Inc. Tampa, FL 33634 |
Approval for a manufacturing site located at iCAD, Inc. Nashua, New Hampshire. |
P010049/S005 3/12/03 Special |
QuickSeal CCS Arterial Closure System |
Sub-Q, Inc. San Clemente, CA 92673 |
Approval for two labeling additions to the approved Premarket Approval Application. |
P010050/S001 3/13/03 Real-Time |
IMMULITE®, IMMULITE® 1000 HBsAg, Confirmatory and IMMULITE® 2000 HBsAg, Confirmatory Kit |
Diagnostic Products Corporation Los Angeles, CA 90045 |
Approval for use of the IMMULITE®, |
P010051/S001 3/13/03 Real-Time |
IMMULITE®, IMMULITE® 1000 Anti-HBc IgM and IMMULITE® 2000 Anti-HBcIgM |
Diagnostic Products Corporation Los Angeles, CA 90045 |
Approval for use of the IMMULITE®, IMMULITE® 1000 Anti-HBc IgM on the IMMULITE® 1000 Automated Analyzer. |
P010052/S001 3/13/03 Real-Time |
IMMULITE®, IMMULITE® 1000 Anti-HBs and IMMULITE® 2000 Anti-HBs |
Diagnostic Products Corporation Los Angeles, CA 90045 |
Approval for use of the IMMULITE®, IMMULITE® 1000 Anti-HBs on the IMMULITE® 1000 Automated Analyzer. |
P010053/S001 3/13/03 Real-Time |
IMMULITE®, IMMULITE® 1000 Anti-HBc and IMMULITE® 2000 Anti-HBc |
Diagnostic Products Corporation Los Angeles, CA 90045 |
Approval for use of the IMMULITE®, IMMULITE® 1000 Anti-HBc on the IMMULITE® 1000 Automated Analyzer. |
P020009/S006 3/12/03 180-Day |
Express/Express2 MR and OTW Coronary Stent System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Approval for an alternate facility located at Boston Scientific Ireland, Ltd. (BSIL), Galway, Ireland for the manufacture of the stent component of the stent system. |
P020014/S001 3/6/03 Real-Time |
Essure™ System |
Conceptus, Inc. San Carlos, CA 94070 |
Approval for a modified delivery catheter called the coil catheter and a modified split introducer. |
P900056/S076 3/7/03 |
Rotablator Rotational Angioplasty System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Modification of the processing parameters within the same sterilization facility. |
P950034/S023 3/25/03 |
Seprafilm® Adhesion Barrier and Seprafilm Procedure Pack |
Genzyme Corporation Cambridge, MA 02134 |
The return of distribution activities for Seprafilm® Adhesion Barrier and Seprafilm Procedure Pack to the Framingham, Massachusetts, manufacturing facility. |
P990075/S010 3/7/03 |
Mentor Saline Filled Breast Implants |
Mentor Corporation Santa Barbara, CA 93111 |
Use of a laser to engrave the Mentor name, logo, device lot number, and device volume onto the patch on the shell of the saline filled breast implants. |
P990075/S011 3/26/03 |
Mentor Saline Filled Breast Implants |
Mentor Corporation Santa Barbara, CA 93111 |
Change for alternative calendaring equipment and an alternative material supplier for the silicone sheeting. |
P000018/S032 3/13/03 |
Novoste™ Beta-Cath™ 3.5F System |
Novoste Corporation Norcross, GA 30093 |
Alternate method of manufacture of the Beta-Cath™ 3.5F System Flushing Adapter. |
P000044/S003 3/20/03 |
Vitros® Immunodiagnostic Products HBsAg Reagent Pack and Calibrator |
Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Addition of raw material supplier for uncoated microwells |
P000052/S018 3/20/03 |
GALILEO® and GALILEO® III Intravascular Radiotherapy Systems |
Guidant Corporation Houston, TX 77054 |
Change in the manufacturing process for Guidant’s P-32 Source Wire. |
P020009/S007 3/7/03 |
Express/Express2™ Coronary Stent System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Manufacturing change in the final cleaning procedure for the stent component of the Express/Express2™ Coronary Stent System. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 58
Summary of PMA Originals Under Review
Total Under Review: 70
Total Active: 34
Total On Hold: 36
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 241
Total Active: 133
Total On Hold: 108
Number Greater Than 180 Days: 1
Summary of All PMA Submissions Received
Originals: 6
Supplements: 49
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 58
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 130.2
FDA Time: 91.4 Days MFR Time: 38.8 Days
Updated 5/12/2003
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH