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PMA Final Decisions Rendered for July 2001

7/5/01

AMPLICOR Hepatitis C Virus (HCV) Test, v2.0

Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Approval for the AMPLICOR Hepatitis C Virus (HCV) Test, v2.0. The device is indicated for: The qualitative detection of HCV RNA in human serum or plasma from blood collected in EDTA (EDTA plasma). The AMPLICOR HCV Test, v2.0 is indicated for patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected to be actively infected with HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

7/3/01

COBAS AMPLICOR Hepatitis C Virus (HCV) Test, v2.0

Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Approval for the COBAS AMPLICOR Hepatitis C Virus (HCV) Test, v2.0. the device is indicated for: The qualitative detection of HCV RNA in human serum or plasma from blood collected in EDTA (EDTA plasma). The COBAS AMPLICOR HCV Test, v2.0 is indicated for patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected to be actively infected with HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active HCV infection.

7/5/01

Dimension® RxL PSA Flex® Reagent Cartridge

Dade Behring, Inc.

Newark, DE

19714

Approval for the Dimension® RxL PSA Flex® Reagent Cartridge. The device is indicated for the following: The PSA method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure prostate specific antigen (PSA) in human serum: 1) as a aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. 2) as an aid in the management (monitoring) of prostate cancer patients.

7/12/01

STAAR Surgical Company AquaFlow™; Collagen Glaucoma Drainage Device, Model CGDD-20

STAAR Surgical Company

Monrovia, CA

91016

Approval for the Model CGDD-20 AquaFlow™™; Collagen Glaucoma Drainage Device. The device is indicated for the maintenance of a sub-scleral space following non-penetrating deep sclerectomy used to facilitate aqueous outflow for the reduction of intraocular pressure in patients with open angle glaucoma where intraocular pressure remains uncontrolled while on maximally tolerated medical therapy.

7/12/01

RapidScreen™; RS-2000

Dues Technologies

Rockville, MD

20850

Approval for the RapidScreen™; RS-2000. The device is a computer-aided detection (CAD) system intended to identify and mark regions of interest (ROIs) on digitized frontal chest radiographs. It identifies features associated with solitary pulmonary nodules form 9 to 30 mm in size, which could represent early -stage lung cancer. The device is intended for use as an aid only after the physician has performed an initial interpretation of the radiograph.

7/17/01

UBIS 5000

Diagnostic Medical Systems

Perols, France

34470

Approval for the UBIS 5000. The UBIS 5000 is a quantitative ultrasound (QUS) bone sonometer and is indicated for the measurement of broadband ultrasound attenuation (BUA) of the calcaneus, as an aid to diagnose osteoporosis and to estimate the risk of subsequent atraumatic fracture. The output is expressed in terms of both BUA and T-score.

180-Day

Avitene UltraFoam Cast Microfibrillar Collagen Hemostat Sponge

Davol, Inc., Subsidiary of C.R. Bard, Inc.

Cranston, RI

02920

Approval for modifications to the slurry preparation and lyophilization process and adjustments to the product specifications resulting from these manufacturing changes.

Real-Time

Etafilcon A Hydrophilic Contact Lenses

Vistakon®, Division of Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32247

Approval for an alternate package integrity test method to support shelf-life and assign expiration dates in lieu of sterility testing.

Real-Time

Collastat® Absorbable Collagen Hemostatic Agents

Integra LifeSciences Corporation

Plainsboro, NJ

08536

Approval for the removal of the neurological exclusion from the Indications Statement.

Panel

Omnicarbon™; Cardiac Valve Prosthesis

Medical CV, Inc.

Inver Grove Heights, MN

55077

Approval for the Omnicarbon™; Cardiac Valve Prosthesis, Aortic Model 3313 in sizes 23, 25, 27 and 29 mm, and Mitral Supra-Annular Model 3523 in sizes 27, 29, 31, and 33 mm. The device is indicated for the replacement of dysfunctioning native or prosthetic aortic or mitral heart valves.

Panel

Integrity Afx DR Model 5346 Dual Chamber Pulse Generator and Programmer Software Model 3307, v2.2a

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Integrity Afx DR Model 5346 Pulse Generator and Programmer Software Model 3307, v2.2a. the device is indicated for use in patients with the following permanent conditions, when associated with symptoms including, but not limited to: 1)syncope

2) presyncope

3) fatigue

4) disorientation

5) or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber pacing is indicated for those patients exhibiting: 1) sick sinus syndrome 2) chronic, symptomatic second- and third degree AV block 3) recurrent Adams-Stokes syndrome 4) 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: 1) normal sinus rhythm with only rare episodes of AV block or sinus arrest 2) chronic atrial fibrillation 3) severe physical disability. Dynamic atrial overdrive is indicated for suppression of atrial tachyarrhythmias including paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for a line extension to the LCS Total Knee System. The line extension consists of adding medium sized component options to approved LCS Total Knee System components.

180-Day

Itrel® 3 System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Itrel® EZ™; Model 7434A Patient Programmer, to be used with the Model 7425 Itrel® 3 Implantable Pulse Generator, and labeling modifications resulting from the introduction of this new patient programmer.

180-Day

Medtronic Itrel® 3 and Synergy™; Spinal Cord Stimulation Systems

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Medtronic Model 7495LZ Low Impedance Extension which will be used with the Itrel®3 and Synergy™; Spinal Cord Stimulation Systems.

180-Day

Nucleus 22 Cochlear Implant System for Adults

Cochlear Corporation

Englewood, CO

80112

Approval for the Crystal Integrity Test System that provides a way of performing a series of integrity checks on either current or past generation Nucleus Cochlear Implants.

180-Day

Frequency Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (Clear and Tinted)

CooperVision

Scottsville, NY

14546

Approval for the Frequency Multifocal (methafilconA) Soft (Hydrophilic) Contact Lenses for extended wear (clear and tinted). The lenses are indicated for extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Special

Boston Scientific Scimed PTCA Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a modification to the warning statement in the Directions for Use manual to expand on the potential affect of re-processing or re-sterilization.

Special

Boston Scientific Scimed Aortic Valvuloplasty™; Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a modification to the warning statement in the Directions for Use manual to expand on the potential affect of re-processing or re-sterilization.

180-Day

Integrity Afx DR Model 5346 Dual Chamber Pulse Generator and Programmer Software Model 3307, v2.2a

St. Jude Medical, Inc.

Sylmar, Ca

91342

Approval for the Integrity Afx DR Model 5346 Pulse Generator and Programmer Software Model 3307, v2.2a. the device is indicated for use in patients with the following permanent conditions, when associated with symptoms including, but not limited to: 1)syncope

2) presyncope

3) fatigue

4) disorientation

5) or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber pacing is indicated for those patients exhibiting: 1) sick sinus syndrome 2) chronic, symptomatic second- and third degree AV block 3) recurrent Adams-Stokes syndrome 4) 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: 1) normal sinus rhythm with only rare episodes of AV block or sinus arrest 2) chronic atrial fibrillation 3) severe physical disability. Dynamic atrial overdrive is indicated for suppression of atrial tachyarrhythmias including paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

180-Day

Nucleus 22 Cochlear Implant System for Children

Cochlear Corporation

Englewood, CO

80112

Approval for the Crystal Integrity Test System that provides a way of performing a series of integrity checks on either current or past generation Nucleus Cochlear Implants.

180-Day

Rotablator® Rotational Angioplasty System,

Rotablator Laser Welding Process

Boston Scientific Corporation

Redmond, WA

98052

Approval for an alternate manufacturing site located at Boston Scientific Cork, Ltd., Cork, Ireland.

Real-Time

Profile™; MD (Models V-186F and V-186HV3), Photon™; DR (Model V-230HV) and Photon™; µ VR/DR Implantable Cardioverter Defibrillators (Models V-194 and V-232)

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the use of a new battery model (WGL 2150) for the legally marketed St. Jude Medical™;Profile™; MD (Models V-186F and V-186HV3), Photon™; DR (Model V-230HV) and Photon™; µ VR/DR Implantable Cardioverter Defibrillators (Models V-194 and V-232). In addition, the supplement requested approval for the use of an alternate IS-1 Receptacle Plug, Model AC-IP-2, for the Photon™; µ devices. The devices, as modified, will be marketed under the trade name Profile™; MD (Models V-186F and V-186HV3) and Photon™; DR (Model V-230HV) Implantable Cardioverter Defibrillators and are indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients may have experienced a cardiac arrest not associated with acute myocardial infarction or have ventricular tachyarrhythmias. In addition, these pulse generators can be used in patients whose primary therapy for hemodynamically significant, sustained ventricular tachycardia is anti-tachycardia pacing; the defibrillation capabilities of these devices provide high-energy therapy in the event that the arrhythmia accelerates. The pulse generators can be implanted in either the pectoral region or the abdominal region, at the physician's discretion. The Photon™; µ VR/DR Implantable Cardioverter Defibrillators (Models V-194 and V-232) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

180-Day

Angio-Seal Vascular Closure Device: Self-Tightening Slipknot (STS)

St. Jude, Medical, Inc.

Minnetonka, MN

55345

Approval for the Self-Tightening Slipknot (STS) modification to the Angio-Seal Vascular Closure Device. The device, as modified, will be marketed under the trade name Angio-Seal Vascular Closure Device: Self-Tightening Slipknot (STS) and is indicated for closing and reducing the time to hemostasis at the femoral arterial puncture site in patients who have undertone a diagnostic angiographic procedure or an interventional procedure using an 8French procedural sheath for the 8F Angio-Seal STS device and a 6F or smaller procedural sheath for the 6F Angio-Seal STS device.

180-Day

Talent Pulse Generator Models DR233 and SR133 and Programmer Software CSO 4.18 UG

ELA Medical , LLC

Plymouth, MN

55441

Approval for the autothreshold feature on two Talent model pacemakers. The device, as modified, will be marketed under the trade name Talent Models DR233 and SR133 and is indicated for the following: Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. The accepted patient conditions warranting chronic cardiac pacing which include: 1) symptomatic paroxysmal or permanent second or third-degree AV block; 2) symptomatic bilateral bundle branch block; 3) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; 4) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; 5) vasovagal syndromes or hypersensitive carotid sinus syndromes. 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 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.

Special

Medtronic Activa® Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the labeling to add a precaution regarding the programming of different neurostimulator models.

Real-Time

Howmedica Osteonics Constrained Acetabular Insert and Trident® Constrained Acetabular Insert

Howmedica Osteonics

Rutherford, NJ

07070

Approval for: 1) A design change to the outer bearing insert of the Trident® Constrained Acetabular Insert - lateralizing the head center by 4 mm; 2) The addition of alumina femoral heads for use with the Howmedica Osteonics Constrained Acetabular Insert and the Trident® Constrained Acetabular Insert.

180-Day

Dual INTERFIX-RP™; Threaded Fusion Devices

Sofamor Danek USA

Memphis, TN

38132

Approval for use of Dual INTERFIX-RP™; Threaded Fusion Devices (instead of the already approved use of a single INTERFIX-RP™; Threaded Fusion Device used in conjunction with an INTERFIX™; Threaded Fusion Device). The unmodified device will continue to be marketed under the trade name INTERFIX-RP™; Threaded Fusion Device and is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INTERFIX-RP™; Threaded Fusion Devices are to be used with autogenous bone graft and implanted via an open anterior approach. Patients receiving the INTERFIX-RP™; Threaded Fusion Devices should have had at least 6 months of nonoperative treatment prior to treatment with the INTERFIX-RP™; Threaded Fusion Device.

180-Day

Nucleus 24 Cochlear Implant System for Adults and Children

Cochlear Corporation

Englewood, CO

80112

Approval for the Crystal Integrity Test System that provides a way of performing a series of integrity checks on either current or past generation Nucleus Cochlear Implants.

180-Day

Belos VR Implantable Cardioverter Defibrillator (ICD) System

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for a new ICD System that includes the following: Belos VR ICD (Model 330 444), Belos Test Housing (Model 331 116), and Belos VR Phylax XM/mycroPhylax/Phylax 06/TMS 1000 Application Software 1-K01.0.A (Model 338 045). The device, as modified is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

180-Day

Model 6943 SPRINT® Lead

Medtronic, Inc.

Shoreview, MN

55126

Approval to withdraw the atrial indication for the Model 6943 Lead.

180-Day

FloSeal® Matrix and Proceed™; Hemostatic Sealants

Fusion Medical Technologies, Inc.

Fremont, CA

94555

Approval for a dry form of FloSeal® Matrix and Proceed™; Hemostatic Sealants.

180-Day

Fusion Matrix-Dry

Fusion Medical Technologies, Inc.

Fremont, CA

94555

Approval for a manufacturing facility located at Fusion Medical Technologies, Inc., Fremont, California.

Real-Time

FocalSeal-L Synthetic Absorbable Sealant

Focal, Inc.

Lexington, MA

02421

Approval for a manufacturing facility located at Chesapeake Biological Laboratories, Inc., Baltimore, MD. The facility will perform the aseptic formulation and filling of Primer Vial 2 of FocalSeal-L Synthetic Absorbable Sealant.

180-Day

Sunlight Omnisense Ultrasound Bone Sonometer

Sunlight Medical Ltd.

Rehovot, Israel

76100

Approval for a manufacturing facility located at Sunlight Medical Ltd., Tel-Aviv, Israel.

180-Day

VISULAS 690s Laser and VISULINK PDT Adapter

Carl Zeiss, Inc.

Thornwood, NY

10594

Approval for modifications to the VISULINK PDT Adapter in order to make the VISULAS 790s laser compatible with both Zeiss and Haag Streit slit lamps. The device, as modified, will be marketed under the trade name VISULINK PDT/U Adapter and is indicated for use with the VISULAS 690s Laser in VISYDYNE™; therapy as sources of photoactivation of VISUDYNE(verteporfin for injection) for the treatment of age-related macular degeneration (AMD) in patients with predominantly classic subfoveal choroidal neovascularization( CNV).

Real-Time

Vibrant® Soundbridge™; System (Audio Processor Models 304 and 404)

Symphonix Devices, Inc.

San Jose, CA

95131

Approval for modification to the mounting of the electronic module assembly, the microphone and the programming socket; change in the physical shape of the magnet from a notched-shape to a full round shape; change in the material of the tip cover of the audio processor (AP) to acrylonitrile-butadiene-styrene copolymer (ABS) and addition of three different colors (light brown, brown and gray) to better match the hair colors of the final users; and pictorial and text changes to reflect the new shape and color of the AP in Reference Manual for Audiologists and Patient User Manual.

180-Day

BiodivYsio™; AS Over-the-Wire (OTW) Phosphorylcholine (PC) Coated Coronary Stent Delivery System (Biodivysio™; AS OTW)

Biocompatibles Cardiovascular, Inc.

San Jose, CA

95113

Approval for the 11 mm and 15 mm Biodivysio™; AS OTW. The device, as modified, will be marketed under the trade name Biodivysio™; AS OTW and is indicated for: "use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length ≤ 25 mm) with a reference vessel diameter ranging from ≥ 3.0 mm to ≤ 4.0 mm and intended to improve coronary lumen diameter. Long term outcome (beyond 6 months) for this permanent implant is unknown at present."

Real-Time

Dimension® PSA Flex® Reagent Cartridge

Dade Behring, Inc.

Newark, DE

19714

Approval for the addition of the Dimension® PSA Flex® Reagent Cartridge for use with the Dimension® Xpand™; System.

Real-Time

Hydro ThermAblator® Endometrial Ablation System

BEI Medical Systems

Teterboro, NJ

07608

Approval for manufacturing changes to the physical structure of the Hydro ThermAblator® unit.

7/16/01

Apligraf™; (Graftskin)

Organogenesis, Inc.

Canton, MA

02021

Change to use an additional shipping container for the Apligraf™; device that would maintain product integrity for a period of 72 hours. The change will allow for greater flexibility with domestic shipments by ensuring product integrity for a longer period, and reduce waste.

7/20/01

STAAR Collamer™; UV Absorbing PC IOL

STAAR Surgical

Monrovia, CA

91016

Change of manufacturing method for STAAR Collamer™; intraocular lenses that involves the addition of a secondary chromophore purification process.

7/27/01

Cordis Checkmate System

Cordis

Corporation

Miami Lakes, FL

33014

Change to the manufacturing processing and colorant of the uni-dummy ribbon assembly to the Checkmate System.

7/3/01

Saline-Filled Breast Implants

McGhan Medical Corporation

Santa Barbara, CA

93111

Addition of a supplier of processed silicone sheeting materials and silicone components used in the fabrication of saline-filled breast implants.

7/13/01

Beta-Cath™; System

Novoste, Corp.

Norcross, GA

30093

Change in the sterilization process.