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PMA Final Decisions Rendered for June 2002

AFFINITY™ Cage System

Medtronic Sofamor Danek

Memphis TN

38132

Approval for the AFFINITY™ Cage System. This device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. AFFINITY™ implants are to be used with autogenous bone graft and implanted via an open, anterior approach.

InSync® ICD Model 7272 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and the Model 9969 Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the InSync® ICD Model 7272 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and the Model 9969 Application Software. The InSync® ICD Model 7272 is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130 ms.

Carpentier-Edwards S.A.V. Bioprosthesis, Model 2650 (Aortic)

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for the Carpentier-Edwards S.A.V. Bioprosthesis, Model 2650 (Aortic), which includes sizes 21, 23, 25 and 27mm. This device is indicated for patients who require replacement of their native or prosthetic aortic valve.

Bausch & Lomb® polymacon Hydrophilic Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14603

Approval for an alternate biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.

Bausch & Lomb® hefilcon A, B and C Hydrophilic Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14603

Approval for an alternate biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.

Itrel®3, Synergy™ and Synergy Versitrel™ Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55421

Approval for updating the Magnetic Resonance Imaging (MRI) text in the spinal cord stimulation pain therapy manuals.

Bausch & Lomb® elastofilcon A Hydrophilic Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14603

Approval for an alternate biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.

Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear

CooperVision, Inc.

Scottsville, NY

14546

Approval for extended wear approval for the Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lenses with UV absorbing monomer. These devices, previously cleared for daily wear under K020392, will be marketed under the trade names listed below for the following indications for use:

Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear and 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 refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Frequency 55 UV Toric lenses are indicated for daily wear and 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 refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less. Frequency 55 UV Multifocal lenses are indicated for daily wear and 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. FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION INTO THE CORNEA AND THE EYE. Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses. FREQUENT/PLANNED REPLACEMENT When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV, Frequency 55 UV Aspheric and Frequency 55 UV Toric lenses are to be cleaned, rinsed, and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner. DISPOSABLE WEAR When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is daily wear or extended wear from 1 to 7 days. Patients should be instructed to discard the lenses at each removal.

Boston Scientific/

SCIMED PTCA/ Perfusion Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for the inclusion of a table specifying the recommended minimum guiding catheter inner diameter in the Instructions for Use (IFU) for the following PTCA catheter models: NC Monorail™, NC Ranger™ 15 mm, NC Ranger™ 22/25/30 mm, NC Ranger™ 16/18 mm and NC Ranger™ 9 mm.

Paragon CRT™ (paflufocon B), Paragon CRT™ 100 (paflufocon D), Paragon Quadra RG™ (paflufocon B), and Paragon Quadra RG™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy

Paragon Vision Sciences

Mesa, AZ

85204

Approval for the following devices and indications: The Paragon CRT™ (paflufocon B) and Paragon CRT™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a Corneal refractive Therapy fitting program for the temporary reduction of myopia up to 6.00 diopters in eyes with astigmatism up to 1.75 diopters. The lenses may be disinfected using only a chemical disinfection system. The Paragon Quadra RG™ (paflufocon B) and Paragon Quadra RG™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a Contact Lens corneal Refractive Therapy fitting program for the temporary reduction of myopia up to 3.00 diopters in eyes with astigmatism up to 1.50 diopters. The lenses may be disinfected using only a chemical disinfection system. NOTE: To maintain the Contact Lens Corneal Refractive Therapy effect of myopia reduction overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intended correction.

Bausch & Lomb® lidofilcon A and B Hydrophilic Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14603

Approval for an alternate biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.

Model 9896 Software for the Jewel Model 7218

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9896 Software for use with the Medtronic Model 2090 Programmer series for use in programming the Jewel Model 7218.

PORT-A-CATH® Epidural Implantable Access System

Deltec, Inc.

St. Paul, MN

55112

Approval for the manufacturing facility located at the finishing/polishing facility located at Eltronic, Coon Rapids, Minnesota.

Rotablator® Rotational Angioplasty System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a manufacturing site located at Boston Scientific Corporation Cork, Ltd. (BSCL), Cork, Ireland, as the manufacturing facility for the molded shuttle seal and lip seal components of the Rotablator® devices.

Model 9896 Software for the Jewel Model 7218

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9896 Software for use with the Medtronic Model 2090 Programmer series for use in programming the Jewel Model 7218.

VasoSeal® 4-5 French System

Datascope Corporation

Mahwah, NJ

07430

Approval to market a smaller version of the VasoSeal® VHD device. The device, as modified, will be marketed under the trade name VasoSeal® 4-5 French System and is indicated for "…use in sealing the femoral arterial puncture site in patients who have undergone diagnostic catheterization procedures using a 4 or 5 French procedural sheath and using a retrograde approach. The VasoSeal® 4-5 French System reduces time to hemostasis, ambulation and discharge in patients who have undergone diagnostic catheterization procedures."

Emdogain® Gel

Biora, Inc.

Chicago, IL

60610

Approval for the revisions to the package insert as listed below based on new data that has been presented in this PMA supplement.

1) Inclusion of the following statement in the Clinical Considerations section: "Histological studies have demonstrated results ranging from complete periodontal regeneration (newly formed cementum, periodontal ligament, and alveolar bone) to repair including new connective tissue attachment (connective tissue adaptation via new cementum) and a new attachment mediated by an epithelial attachment (long junctional epithelium). The long-term stability of the regenerated tissue has not been established. As in any periodontal surgical therapy, defect morphology, surgical technique and host response are important parameters for successful outcomes."

2) Inclusion of the following statements in the Clinical Considerations section: a) patients tend to report less post-surgical discomfort; b) clinicians have reported on enhanced wound healing.

BTE (Behind-The-Ear) System Sensor (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the BTE System Sensor, an accessory item to be offered for use with the BTE Sound Processor for limited verification of system functionality.

CPI Switch Box

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the CPI Switch Box (formerly A/B Switch Box). The CPI Switch Box is an interface box to facilitate the connection of two programming cables to the existing CPI (Clinician’s Programming Interface).

PreservCyt® Alternative Transport Medium for Roche COBAS AMPLICOR™ CT/NG Test.

CYTYC Corporation

Boxborough, MA

01719

Approval for the PreservCyt® Solution component of the ThinPrep® 2000 System to be used as an alternative collection and transport medium for gynecologic specimens tested with the Roche COBAS AMPLICOR™ CT/NG Test.

Bausch & Lomb® alphafilcon A Hydrophilic Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14603

Approval for an alternate biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.

CV232 SRE™ Pre-rolled Acrylic Intraocular Lens (IOL)

CIBA Vision Corporaion

Duluth, GA

30097

Approval for a trade name change of the MemoryLens IOL. The device will be marketed under the trade name CV232 SRE™ Pre-rolled Acrylic Intraocular Lens and is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age of older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.

Closer S™ 6 Fr. Suture-Mediated Closure (SMC) System

Perclose, An Abbott Laboratories Company

Redwood City, CA

94063

Approval to modify the outer diameter of the needle shaft of the Closer S™ 6 Fr. SMC, from 0.020" (inches) to 0.022".

CPI Switch Box

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the CPI Switch Box (formerly A/B Switch Box). The CPI Switch Box is an interface box to facilitate the connection of two programming cables to the existing CPI (Clinician’s Programming Interface).

BTE (Behind-The-Ear) System Sensor (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the BTE System Sensor, an accessory item to be offered for use with the BTE Sound Processor for limited verification of system functionality.

NeuroCybernetic Prosthesis (NCP®) System, VNS Therapy Tunneler, Model 402 (Version 2) and VNS Therapy Accessory Pack, Model 502

Cyberonics, Inc.

Houston, TX

77058

Approval for modifications to the existing Model 402 Tunneling Tool (Version 1), resulting in the new VNS Therapy Tunneler, Model 402 (Version 2), and modifications to the existing Model 500 Accessory Pack, resulting in the new VNS Therapy Accessory Pack, Model 502.

VNS Therapy ™ System (VNS Therapy Pulse, Model 102 Generator and VNS Therapy Lead, Model 302, Version 1.1

Cyberonics, Inc.

Houston, TX

77058

Approval for modifications to the existing Model 101 (Version 2) In-Line NCP Pulse Generator and Model 302 (Version 1) In-Line NCP Bipolar Lead, resulting in the new VNS Therapy Pulse, Model 102 Generator and the VNS Therapy Lead, Model 302 (Version 1.1). The device, as modified, will be marketed under the trade name VNS Therapy™ System.

NeuroCybernetic Prosthesis (NCP®) System, Model 250 Programming Software, Version 6.1 (Build 5)

Cyberonics, Inc.

Houston, TX

77058

Approval for modifications to the existing Model 250 Programming Software Version 6.1 (Build 4), resulting in the new Version 6.1 (Build 5).

MULTI-LINK RX and OTW PIXEL™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95052

Approval for inclusion of six-month trial data in the Instructions for Use booklet for the Multi-Link RX and OTW PIXEL™ Coronary Stent Systems.

Nucleus 24 Cochlear Implant System for Adults and Children With CI 11+11+2M Double Array Cochlear Implant

Cochlear Corporation

Englewood, CO

80112

Approval for the Nucleus 24 Cochlear Implant System for Adults and Children with CI 11+11+2M Double Array Cochlear Implant. The device, as modified, will be marketed under the trade name Nucleus 24 Implant System for Adults and Children with 11+11+2M Double Array and is indicated for patients who have cochlear ossification preventing full insertion of a standard Nucleus 24 cochlear implant electrode array.

Nucleus 24 Cochlear Implant System with Stylet Replacement Tool

Cochlear Americas

Englewood, CO

80112

Approval for a Stylet Replacement Tool.

Chilli® Cooled Ablation System

Boston Scientific/ EP Technologies, Inc.

San Jose, CA

95134

Approval for: 1) use of a compatible radiofrequency (RF) generator for delivery of RF energy through the tip of the Chilli® Cooled Ablation Catheter and the addition of accessories to connect the catheter to the RF Generator; 2) a temperature sensor converter (Model 2067 Thermocouple to Thermistor Translator (TTT) Module) for the thermocouple output of the Chilli® Cooled Ablation Catheter to the thermistor input of the compatible RF Generator; and 3) a separate, compatible pump (Model 8005 Pump System) for delivery of fluid flow through the tip of the Chilli®/Cooled Ablation Catheter and a new tubing kit accessory (Model 2104 sterile disposable tube set) which connects the catheter to the pump.

Bausch & Lomb® balafilcon A Hydrophilic Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14603

Approval for an alternate biological indicator, the 3M™ Attest™ Rapid Readout Biological Indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.

Sharpx® Needle Destruction Unit

BioMedical Disposal, Inc.

Norcross, GA

30092

Approval for the expansion of the needle gauge range to include 18-30 gauge needles, and minor labeling changes.

Model MMT-7002 Glucose Sensor

Medtronic MiniMed

Northridge, CA

91325

Approval for an additional manufacturing facility located at Medtronic MimiMed, Northridge, California.

BAK/Cervical (BAK/C®) Interbody Fusion System

Centerpulse Spine-Tech

Minneapolis, MN

55439

Approval for the post-approval study protocol for the BAK/C® device. The post-approval study has been submitted to comply with the conditions of approval outlined in the April 20, 2001, approval order for P980048.

CoStasis Surgical Hemostat

Cohesion Technologies

Palo Alto, CA

94303

Approval for a manufacturing site located at Cohesion Technologies, Palo Alto, California.

PepGen P-15 and PepGen P-15 Flow

Dentsply CeraMed Dental Corporation

Lakewood, CO

80228

Approval for the addition of the following indications for use; augmentation of bony defects of the alveolar ridge, filling tooth extraction sites, and sinus elevation grafting. The device, as modified, will be marketed under the trade names PepGen P-15 and PepGen P-15 Flow.

Cordis Checkmate System

Cordis Corporation

Miami Lakes, FL

33014

Approval for a modification to the existing radiation dosimetry protocol from a protocol that is based on intravascular ultrasound (IVUS) to a protocol that prescribes a fixed dose of 14 Gy at a distance of 2 mm from the centerline of the source and is indicated for the treatment of native coronary arteries (2.75 – 4.0 mm in diameter and lesions up to and including 45 mm in length) with in-stent restenosis following percutaneous revascularization using current interventional techniques.

DiaSorin ETI-AB-AUK PLUS Assay

DiaSorin, Inc.

Saluggia, Italy

13040

Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the March 30, 2001 approval order for P990042.

ATS Open Pivot® Bileaflet Aortic Valved Graft, Models 502AG21 through 502AG29

ATS Medical

Minneapolis, MN

55447

Approval to combine the ATS Open Pivot Bileaflet Heart Valve (approved on October 13, 2000 under P990046) with the Meadox Hemashield Woven Double Velour Vascular Graft (approved on May 11, 1993 under P840029/S005). The device, as modified, will be marketed under the trade name ATS Open Pivot Bileaflet Aortic Valved Graft, Models 502AG21 through 502AG29, and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required.

Optical Biopsy™ System

SpectraScience, Inc.

Minneapolis, MN

55447

Approval for the use of the Reusable WavSTAT™ Optical Biopsy Forceps with the WavSTAT™ Optical Biopsy System.

OxiFirst™ Fetal Oxygen Saturation Monitoring System

Nellcor Puritan Bennett, Tyco Healthcare Group

Pleasanton, CA

94588

Approval for software upgrade.

Chilli® Cooled Ablation System

Boston Scientific/ EP Technologies, Inc.

San Jose, CA

95134

Approval for: 1) use of a compatible radiofrequency (RF) generator for delivery of RF energy through the tip of the Chilli® Cooled Ablation Catheter and the addition of accessories to connect the catheter to the RF Generator; 2) a temperature sensor converter (Model 2067 Thermocouple to Thermistor Translator (TTT) Module) for the thermocouple output of the Chilli® Cooled Ablation Catheter to the thermistor input of the compatible RF Generator; and 3) a separate, compatible pump (Model 8005 Pump System) for delivery of fluid flow through the tip of the Chilli®/Cooled Ablation Catheter and a new tubing kit accessory (Model 2104 sterile disposable tube set) which connects the catheter to the pump.

GE Medical Systems Senographe 2000D Full Field Digital Mammography System

GE Medical Systems

Milwaukee, WI

53188

Approval for the addition of GRME as an alternative supplier of the Generator component of the General Electric Medical Systems (GEMS) Senographe 2000D Full-Field Digital Mammography (FFDM) X-ray System.

Senographe 2000D Full Field Digital Mammography System

General Electric Company

Milwaukee, WI

53201

Approval for a new DICOM box on the Kodak 8610 printer.

Mentor Alpha 1® Inflatable Penile Prosthesis with Hydrophilic Coating

Mentor Corporation

Santa Barbara, CA

93111

Approval for hydrophilic coating of the device. The device, as modified, will be marketed under the trade name Mentor Alpha 1® Inflatable Penile Prosthesis with Hydrophilic Coating and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

TMx-2000 BPH Thermotherapy System

TherMatrx, Inc.

Northbrook, IL

60062

Approval for an additional manufacturing facility located at Tricor Systems, Inc., Elgin , Illinois. The TMX-2000 Control System will be manufactured at this facility.

Indermil™ Tissue Adhesive

United States Surgical

Norwalk, CT

06856

Approval for labeling changes to include an extension to the labeled device shelf-life from 12 months to 24 months and a 4-week ambient storage claim.

QuickSeal CCS Arterial Closure System

SUB-Q, Inc.

San Clemente, CA

92673

Approval for extending the shelf life of the approved QuickSeal Femoral Arterial Closure System from 6 to 24 months.

Percutaneous Transluminal Coronary Angioplasty (PTCA)

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

Percutaneous Transliminal Coronary Angioplasty (PTCA)

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

Aortic Valvuloplasty™ Balloon Dilatation Catheter

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

Rotablator® Rotational Angioplasty System

Boston Scientific Scimed

Maple Grove, MN

55311

Change in the burr adhesion process.

Rotablator® Rotational Angioplasty System

Boston Scientific Scimed

Maple Grove, MN

55311

Alternate manufacturing process to the electroplating process for the Rotablator System Floppy Gold guide wire.

WALLSTENT® Transjuglar Intrahepatic Portosystemic Shunt (TIPS) Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

WALLSTENT® Iliac Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

Radius™ Coronary Stent with Delivery Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

NIR® Premounted Stent Delivery Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

WALLSTENT® Venous Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Alternative bacterial endotoxin testing method, the Kinetic-Turbidimetric method, to test water samples and product extracts.

FloSeal® Matrix Hemostatic Sealant

Fusion Medical Technologies, Inc.

Fremont, CA

94555

Convert to Cleanroom and Controlled Environment Standard ISO 14644-1:1999.

GE Medical Systems Senographe 2000D Full Field Digital Mammography System

GE Medical Systems

Milwaukee, WI

53188

Addition of a Siemens Model 6GF6300-1BW04 AWS monitor with PDS CRT as an alternative supplier of the AWS monitor component of the

General Electric Medical Systems (GEMS) Senographe 2000D Full-Field Digital Mammography (FFDM) x-ray system and suppression of the AWS Monitor calibration test.

Mentor Saline-Filled and Spectrum™ Mammary Prostheses

Mentor Corp.

Santa Barbara, CA

93111

Change of supplier for molded silicone components to Porges, Division of Mentor, Sarlat Sedex, France and a change in supplier of the raw material from Dow Corning to NuSil for one molded component.

Novoste™ Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Change in the manufacturing process to eliminate an inspection test.

CardioSEAL® Septal Occlusion System with Qwik Load

NMT Medical

Boston, MA

02210

Change to the incoming inspection for Tyvek/Mylar pouches used for packaging the implant and delivery system.

Indermil™ Tissue Adhesive

United States Surgical, a Division of Tyco Healthcare

Norwalk, CT

06856

Packaging change from a 5 and 20 unit dose configuration to a new 12 and 24 unit dose configuration. The packaging changes will make greater use of the space within the packaging and allow more units to be shipped in the same or slightly increased volume packaging.

NovaSure™ Impedance Controlled Endometrial Ablation System (GEN2)

Novacept, Inc.

Palo Alto, CA

94303

Modifications to the manufacturing processes for the NovaSure disposable device, including injection molding of the plastic components, incorporation of the non-conducting lines of the array into the PEAK II knitting process, and the incorporation of three separate tubes into a single multi-lumen extrusion.