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PMA Final Decisions Rendered for November 1999

11/12/99

LaserScan LSX Excimer Laser System for photorefractive keratectomy for myopia

LaserSight Technologies, Inc.

Winter Park, FL

32792

Approval for the LaserScan LSX Excimer Laser System. The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1.0 to less than -6.0 diopters (D) with less than or equal to 1.0 D of astigmatism; in patients with documentation of a stable manifest refraction (± 0.5D) over the prior one year; and in patients who are 18 years of age or older.

11/19/99

VISX, Inc. Excimer Laser System Model C (STAR S2) for Laser in situ Keratomileusis (LASIK) for the Correction of Myopia with or without Astigmatism

VISX, Inc.

Santa Clara, CA

95051

Approval for the VISX Excimer Laser System Model C (STAR S2) which included the right to reference information contained in P930016 from VISX, Inc., of Santa Clara, CA. This device is indicated to perfrom LASIK: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14.0 diopters (D) with or without -0.5 D to -5.0 D of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.

11/12/99

Hydroview® Composite Hydrogel Foldable Ultraviolet-Absorbing Posterior Chamber Intraocular Lens, Model H60M

Bausch & Lomb Surgical

Clearwater, Fl

33759

This device is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed by extracapsular extraction methods. The lens is intended for placement in the capsular bag.

11/18/99

CSI™ (crofilcon A) Extended Wear Soft (Hydrophilic) Contact Lens

Wesley Jessen Corporation

Des Plaines, IL

60018-5903

Approval for a manufacturing site transfer of the CTL process for the CSI™ Lens from San Diego, CA to Wesley Jessen, Inc., Route 173, Kilometer 1.1, El Jibaro Industrial Park, P.O. Box 1980, Cidra, Puerto Rico 00739.

11/5/99

Vitek® 2 Gram Negative Susceptibility Test for Trimethoprim/

sulfamethoxazole

BioMerieux, Inc.

Hazelwood, MI

63042-2320

Approval for the addition of the antibiotic trimethoprim/

sulfamethoxazole at concentrations of 0.5/9.5, 2/38 and 16/304m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to trimethoprim/

sulfamethoxazole in the range of £ 1/19 to ³ 16/304m g/ml.

11/10/99

Vitek® 2 Gram Negative Susceptibility Test for Aztreonam

BioMerieux, Inc.

Hazelwood, MI

63042-2320

Approval for the addition of the antibiotic aztreonam at concentrations of 2, 8 and 32m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to aztreonam in the range of £ 1 to ³ 64m g/ml.

11/8/99

Vitek® 2 Gram Negative Susceptibility Test for Cefotetan

BioMerieux, Inc.

Hazelwood, MI

63042-2320

Approval for the addition of the antibiotic cefotetan at concentrations of 2, 8, and 32 m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. This device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to cefotetan in the range of £ 4 to ³ 64m g/ml.

11/5/99

Vitek® 2 Gram Negative Susceptibility Test for Levofloxacin

BioMerieux, Inc.

Hazelwood, MI

63042-2320

Approval for the addition of the antibiotic levofloxacin at concentrations of 0.5, 4 and 8m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to levofloxacin in the range of £ 0.25 to ³ 8m g/ml.

11/15/99

Vitek® 2 Gram Positive Susceptibility Test for Benzylpenicillin

BioMerieux, Inc.

Hazelwood, MI

63042-2320

Approval for the addition of the antibiotic benzylpenicillin at concentrations of 0.125, 0.25, 1, 2, 8 and 64m g/ml to the Vitek® 2 Gram Positive Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Positive Susceptibility test Cards for the susceptibility testing of gram positive organism to benzylpenicillin in the range of £ 0.03 to ³ 64m g/ml.

11/10/99

Vitek® 2 Advanced Expert System Software

BioMerieux, Inc.

Hazelwood, MI

63042-2320

Approval for the Vitek® 2 Advanced Expert System as an optional software accessory for the Vitek® 2 Susceptibility Test System.

11/4/99

JEM Series Endotracheal Tube Changers

Instrumentation Industries, Inc.

Bethel Park, PA

15102

Approval for a manufacturing site located at FBK Medical Tubing, Inc., 511 Cobb St., Birmingham, AL 35209.

11/10/99

LCS Total Knee System –Gas Plasma Sterilization for Porous Coated Rotating Patella Components

DePuy Orthopaedics, Inc.

Warsaw, IN

46581-0988

Approval for gas plasma sterilization of the porous coated rotating patella components of the LCS Total Knee System.

11/22/99

LCS Total Knee System – addition of the LCS Patellofemoral Replacement System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581-0988

Approval for several sizes of newly developed trochlear groove implants to be used in conjunction with currently marketed patellar componenets of the LCS Total Knee System for the purpose of resurfacing the patellofemoral joint. This device is indicated for patients with isolated patellofemoral osteoarthritis, a history of patellar dislocation or patellar fracture, or a failed previous surgery where pain, deformity or dysfunction persist. The trochlear implants are intended for cemented use only.

11/19/99

Dual Channel Itrel® Synergy™ Neurostimulation System Model 7427 Implantable Pulse Generator, Model 7435 Patient Programmer, Model 7459 MemoryMod Software, and Model 3550-09 Accessory Kit Itrel® 3 Spinal Cord Stimulation System (Model 7459 MemoryMod Software)

Medtronic Neurological

Minneapolis, MN

55421-1200

Approval for the Dual Chamber Intrel® Synergy™ Neurostimulation System as well as the Model 7459 MemoryMod Software for use with the existing Itrel® 3 Spinal Cord Stimulation System.

11/5/99

Programmer Software Model 2881 version 1.4

Guidant Corporation

St. Paul, MN

55112-5798

Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Programmers, to correct software anomalies and update features.

11/24/99

Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, Encore Toric, CooperFlex, and Onevue (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

CooperVision

Scottsville, NY

14546

Approval for adding disposable and frequent/planned replacement to the wearing schedule.

11/19/99

STS-T Lithotripter

Medstone International, Inc.

Aliso Viejo, CA

92656-4114

Approval for minor changes to the hardware (i.e., modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positioner, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i.e., upgrade to version 1999.3), as well as minor changes to the device's labeling.

11/8/99

AMO® Vitrax® Viscoelastic Solution

Allergan Medical Optics, Inc.

Irvine, CA

92713-9534

Approval to 1) extend the finished product UV absorbance specification from 0.012 AU to 0.016 AU and 2) eliminate the UV absorbance specification from the 24 month shelf-life.

11/10/99

AVPlus™ Dx Model 1368 Single-Pass Pacing Lead Tendril™ Dx Pacing Lead Family Passive Plus™ Dx Pacing Lead Family

St. Jude Medical

Sylmar, CA

91342

Approval for the use of two alternate medical adhesives.

11/24/99

BVS 5000® Bi-Ventricular Support System

ABIOMED Cardiovascular, Inc.

Danvers, MA

01923

Approval for a 10mm Arterial Cannula with 10mm Hemashield® woven graft.

11/5/99

Programmer Software Model 2881 version 1.4

Guidant Corporation

St. Paul, MN

55112-5798

Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Programmers, to correct software anomalies and update features.

11/8/99

CLARION® Multi-Strategy Adult Cochlear Implant (SCLIN 2000 Device Fitting Software)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the SCLIN 2000 Device Fitting Software for the CLARION® Multi-Strategy Cochlear Implant (Adult).

11/5/99

Prostatron™ Praktis

EDAP Technomed, Inc.

Norcross, GA

30071

Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.

11/10/99

The Heart Laser™ CO₂ TMR System

PLC Medical Systems, Inc.

Franklin, MA

02038

Approval for a new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the TMR Disposable Kit (an accessory for The Heart Laser™ System). In addition, approval is requested to extend the shelf life for the TMR Disposable Kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.

11/23/99

TVL-ADX Model 1559 Tachyarrhythmia Lead System

St. Jude Medical

Sunnydale, CA

94086-6527

Approval for the TVL-ADX Model 1559 Tachyarrhythmia Lead System.

11/19/99

CSO 4.10UG Programmer Software

ELA Medical

Plymouth, MN

55441

Approval for the CSO 4.10 UG Programmer Software, for use with the ELA programmers.

11/26/99

Transcyte™

Advanced Tissue Sciences

La Jolla, CA

92037-1005

Approval for changing the frequency of the in-process sterility testing conducted on the device.

11/10/99

AVPlus™ Dx Model 1368 Single-Pass Pacing Lead Tendril™ Dx Pacing Lead Family Passive Plus™ Dx Pacing Lead Family

St. Jude Medical

Sylmar, CA

91342

Approval for the use of two alternate medical adhesives.

11/15/99

Livewire TC™ Cardiac Ablation System

DAIG Corporation

Minnetonka, MN

55345-2126

Approval for eight new catheters marketed under the trade name Livewire TC™ Steerable Electrophysiology Catheter with Universal Temperature Monitoring and the Livewire TC™ Steerable Electrophysiology Thermistor Extension Cable. The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.

11/10/99

AVPlus™ Dx Model 1368 Single-Pass Pacing Lead Tendril™ Dx Pacing Lead Family Passive Plus™ Dx Pacing Lead Family

St. Jude Medical

Sylmar, CA

91342

Approval for the use of two alternate medical adhesives.

11/22/99

The Closer™ Percutaneous Vascular Surgery (PVS) Device and Accessories

Perclose, Inc.

Redwood City, CA

94063

Approval for the Closer™ PVS Device and the following accessories: the Perclose Mini Knot Pusher, Perclose Snared Knot Pusher and the Clincher™ Knot Tying Device. The device is indicated for the percutaneous delivery of suture for closing hte common femoral artery access sie of patients who have undergone diagnostic catheterization procedures using 5 to 6 Fr. sheaths. The Closer™ 6 Fr. PVS System reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catherization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations in the device labeling).

11/10/99

S-ROM® Poly-Dial Constrained Liner

DePuy Orthopaedics, Inc.

Warsaw, IN

46581-0988

Approval for a cleaning and packaging facility located at DePuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw, IN 46581.

11/18/99

CLARION® Multi-Strategy Pediatric Cochlear Implant (SCLIN 2000 Device Fitting Software)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the SCLIN 2000 Device Fitting Software for the CLARION® Multi-Strategy Cochlear Implant (Pediatric).

11/4/99

Medtronic® Interstim® System for Urinary Control

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a revised Implant Patient Manual that will be given to the patient prior to the implant surgery.

11/2/99

ThermaChoice™ II Uterine Balloon Therapy (UBT) System

Gynecare, Inc.

Menlo Park, CA

94025

Approval for the following modifications: 1) change in balloon material from latex to silicone; 2) addition of fluid circulation mechanism (i.e., impeller) within catheter; 3) change in software language from Assembly to a combination of C and Assembly; and 4) other minor modifications to the device system. In addition, changes also include a change in the manufacturer of the catheter controller to RELA, Inc., located at 410 S. Sunset, Bldg., D., Longmont, CO 80501. The device is intended for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.

11/15/99

T-Scan 2000

TransScan Medical, Inc.

c/o Hogan & Harson

555 Thirteenth Street, N.W.

Washington, D.C. 20004

Approval for changes in the electronic circuitry, elimination of all but the 200 Hz frequency, optional small probe, and optional phantom. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADS™ categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.

11/16/99

Medtronic AVE (AVE) S670 with Discrete Technology™ Over-The Wire Coronary Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for the Medtronic AVE (AVE) S670 with Discrete Technology™ Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present.

11/23/99

Medtronic AVE (AVE) S670 with Discrete Technology™ Rapid Exchange Coronary Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present. The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressue during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone PTCA perfusion catheter.

11/23/99

PureVision™ (balafilcon A) Visibility Tinted Contact Lens

Bausch & Lomb

Rochester, NY

14603-0450

Approval for: 1) adding a contraindication for the use of Allergan Ultracare disinfecting System to the product labeling (package insert/fitting guide and patient information booklet for frequent replacement wear); 2) removing references to thermal disinfection in the product labeling (package insert and patient information booklets); and 3) adding "The BAUSCH & LOMB® PureVision™ (balafilcon A) Visibility Tinted Contact Lenses are manufactured by a cast-molding process and are surface treated by the Performa™ surface treatment process which transforms hydrophobic silicone to hydrophilic silicate" to the Description section of the package insert/fitting guide.

11/29/99

Magic WALLSTENT® Self-Expanding Coronary Stent

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311-1566

Approval for a change to the package labeling and Instructions for approval for a change to the package labeling and Instructions for Use.

11/10/99

Vitatron Diva Platform IPGs

Vitatron, Inc.

Minneapolis, MN 55459

Approval for a manufacturing site located at Medtronic Swiss Manufacturing Facility, Medtronic S.A., Route du Molliau, 1131, Tolochenaz, Switzerland.

11/12/99

Vitatron Diva Implantable Pulse Generators

Vitatron, Inc.

Minneapolis, MN

55459

Approval for modifications to the Diva family implantable pulse generator: adding the following new models: Diamond II Model 820E; Ruby II Model 720E; Topaz II Model 520E; Jade II Model 220E; vita DDDr Model 810E; Vita DDD Model 710E; Vita VVIR Model 310E. Introduction of 3.2mm models the Diamond II Model 822E and Topaz II Model 522E; modifying the programmer software to recognize the new model numbers; modifying the header to be consistent with the Medtronic Kappa 400; move to mulitple feedthroughs from a single feedthrough design; change the tissue contracting materials and packaging to those currently used in Medtronic's Kappa 400; and modify the labeling to accommodate the additional models and attendant software changes.

11/2/99

Polymacon Contact Lenses

Bausch & Lomb

Rochester, NY

14603-0450

The 30-Day Notice requested introduction of a manufacturing process change for the Polymacon Contact Lenses for extended wear. The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material. The manufacturing process and procedures will not change.

11/29/99

UVAR® XTS® PHOTOPHERESIS System

THERAKOS

Exton, PA

19341

The 30-Day Notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits

11/3/99

PTCA Catheters

Boston Scientific, Scimed, Inc.

Maple Grove, MN

55311-1566

The 30-Day Notice requested an alternate manufacturing method of attaching the proximal shaft to t he core wire sub-assembly on the following PTCA catheters: Viva™ P860019/S143; Maxxum™ P860019/S144; NC Maxxum™ P860019/S150; Adante™ P860019/S154.

11/23/99

INTEGRA® Artificial Skin, Dermal Regeneration Template

Integra LifeSciences Corporation

Plainsboro, NJ

08536

The 30-Day Notice requested a change to the Quality Control test used to determine the chondroitin-6-sulfate content in INTEGRA® Artificial Skin, Dermal Regeneration Template.

11/30/99

EPT-1000 Cardiac Ablation System

Boston Scientific Corporation

San Jose, CA

95134

The 30-Day Notice requested a change in the manufacturing (sterilization) process for therapeutic ablation catheters used with the EPT-1000 that will allow the use of alternate biological indicators with a reduced incubation time.

11/4/99

NIR™ Premounted Stent System

Boston Scientific Corporation

Natick, MA

01760-1537

The 30-Day Notice requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the NIR™ PRIMO™ Premounted Stent Delivery System.