P980037

3/12/99

AngioJet® Rheolytic™ Thrombectomy System (AngioJet® Drive Unit, AngioJet® Pump Set, and AngioJet® Rheolytic™ Thrombectomy LF140 Catheter)

Possis Medical, Inc.

Minneapolis, MN

55433-8003

Approval for the AngioJet® Rheolytic™ Thrombectomy System (AngioJet® Drive Unite, AngioJet® Pump Set, and AngioJet® Rheolytic™ Thrombectomy LF140 Catheter). This device is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesion in vessels > 2.0mm in diameter prior to balloon

angioplasty or stent placement.

N17679/S034

3/17/99

The Preference® Standard, CooperClear™, CV43™, Vantage® and Vantage Accents (tetrafilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear (Spherical and Toric, Clear and Handling tint with In-Monomer Tinting Process, Cast-molded)

COOPERVISION, Inc.

Scottsville, NY

14546

Approval for an alternate tinting process, In-Monomer-Tinting Process for referenced devices.

N18033/S032*

3/16/99

Molded etafilcon A hydrophilic contact lens with and without UV blocker, clear and with visibility tint

Vistakon

Johnson & Johnson Vision Products, Inc.

Jacksonville, FL

32247

Approval for an alternate shelf-life protocol.

P790027/S063*

3/15/99

PMMA Posterior Chamber Intraocular Lenses

Bausch & Lomb Surgical

Clearwater, FL

33759

Approval for minor revision to the labeling and an alternate sterilization method.

P810046/S197

3/4/99

ACS RX Gemini™ Coronary Dilatation Catheters

Guidant Corporation

Santa Clara, CA

95052

Approval for the implementation of an additional quality control inspection to further ensure that the balloon size designation on the proximal adaptor is correct for the ACS RX Gemini™ Coronary Dilatation Catheter.

P840008/S067

3/12/99

Dornier Lithotripter – Doli S and Compact Delta

Dornier Medical Systems, Inc.

Kennesaw, GA

30144

Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.

P850020/S011

3/15/99

Prosorba® Column

Cypress Bioscience, Inc.

San Diego, CA

92121

Approval for the Prosorba® Column. This device is indicated for: 1) use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containing circulating immune complexes from plasma in patients with idiopathic thrombocytopenic purpura (ITP) having platelet counts less than 100,000mm³ and 2) for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients with long-standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).

P850059/S020*

3/15/99

PMMA Anterior Chamber Intraocular Lenses

Bausch & Lomb Surgical

Clearwater, FL

33759

Approval for minor revision to the labeling and an alternate sterilization method.

P860040/S015

3/4/99

BIOCURVE SOFT TORIC FW (methafilcon A) CONTACT LENS (Clear and Tinted)

Cal Bionics, Inc.

Novato, CA

94947-4223

Approval for a toric configuration of the BIOCURVE SOFT FW (methafilcon A)

CONTACT LENS (clear and handling tint). The device, as modified, will be marketed under the trade name BIOCURVE SOFT TORIC FW (methafilcon A) CONTACT LENS and is indicated for daily wear or extended wear by not-aphakic persons with non-diseased eyes. The lenses are for the correct of refractive ametropia (myopia, hyperopia, and astigmatism). The spherical lens may be worn by persons with up to 1.50 diopters of astigmatism that

does not interfere with visual acuity; the toric lens corrects astigmatism of 5 diopters or less. Lenses prescribed for extended wear may be worn from 1 to 7 days between removals for cleaning, rinsing, and disinfection or replacement, as recommended by the eyecare practitioner. The lenses may be disinfected using a chemical disinfection system only.

P860004/S042*

3/18/99

Medtronic Synchromed™ Infusion System

Medtronic, Inc.

Minneapolis, MN

55440-1200

Approval for addition of an alternate catheter port for use with the SynchroMed pump, Model 8508 CAP; Addition of an Application Specific Integrated Circuit (ASIC) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from SynchroMed™ to SynchroMed EL™ ; change in model numbers (new model numbers represent new SynchroMed EL Pumps); and changes to labeling.

P870013/S012*

3/15/99

PMMA Anterior Chamber Intraocular Lenses

Bausch & Lomb Surgical

Clearwater, FL

33759

Approval for minor revision to the labeling and an alternate sterilization method.

P870015/S031

3/11/99

STS-T Lithotripter

Medstone International, Inc.

Aliso Viejo, CA

92656-4114

Approval for minor software upgrades to version 1999.0, minor hardware changes, and associated changes to the device labeling.

P870072/S009

3/19/99

Thoratec Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval to move manufacturing facility located at Thoratec Lab, 2023 Eighth St., Berkeley, CA, to Thoratec Lab, 6035 Stoneridge Dr., Pleasanton, CA.

P870076/S007

3/2/99

Circon Cabot Falope-Ring® Band Contraceptive Tubal Occlusion System

Circon Corporation

Santa Barbara, CA

93117-3019

Approval for dimensional and design changes of the Falope-Ring® Applicators.

P880091/S015

3/15/99

ELASTIC™ and ELASTIMIDE™ Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses

STAAR Surgical Company

Monrovia, CA

91016

Approval for a modification to the manufacturing process.

P890064/S006

3/17/99

Digene HPV Test Using Hybrid Capture® II Technology

Digene Diagnostics, Inc.

Silver Spring, MD

20904

Approval for chaning the solid phase on which the RNA:DNA hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (Digene Cervical Sampler), addition of the Digene Sample Conversion Kit, and the addition of new assay performance characteristics. The device, as modified, will be marketed under the trade name Digene HPV Test Using Hybrid Capture® II Technology (HCII HPV) with The following indications: The Digene HPV Test using Hybrid Capture II technology is a nucleic acid signal enhanced solution hybridization microplate assay using chemiluminescence for the qualitative detection of eighteen types of human papillomavirus (HPV) DNA in cervical specimens. The Digene HPV Test can differentiate between two HPV DNA groups: low risk HPV types 6/11/42/43/44; and high/intermediate risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68, but cannot determine the specific HPV type present. Cervical specimens which may be tested with the Digene HPV Test include the following: 1) Specimens collected with the Digene Cervical Sampler; 2) Biopsies collected in the Digene Specimen Transport Medium; 3) Specimens collected using a broom-type collection device and placed in Cytye PreservCyt Solution (refer to the Digen Sample Conversion Kit package insert for complete details).

P900043/S014

3/31/99

PALMAZ-SCHATZ™ Crown Balloon-Expandable Stent with PowerGrip™ Over-the-Wire Delivery System

Cordis Corporation

Warren, NJ

07059

Approval for an extension in shelf life from 1 year to 18 months.

P900060/S018

3/17/99

Sulzer Carbomedics Orbis™ Prosthetic Heart Valve

Sulzer Carbomedics, Inc.

Austin, TX

78752

Approval for a sewing cuff modification of the CarboMedics® Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name Sulzer Carbomedics Orbis™ Prosthetic Heart Valve and will be available in the following model numbers and sizes: Model 100 (aortic sizes 19, 21, 23, 25, 27, 29, and 31mm), and Model 200 (mitral sizes 21, 23, 25, 27, 29, 31, and 33mm).

P910001/S013

3/12/99

Spectranetics CVX-300® Excimer Laser System, Software Versions 3.51 and 3.6

Spectranetics Corporation

Colorado Springs, CO

80907-5186

Approval for Software Versions 3.51 and 3.6.

P910016/S011

3/4/99

LCS® Unicompartmental Knee System

DePuy, Inc.

Warsaw, IN

46581-0988

Approval for a sterilization site located at DePuy International Ltd., St. Anthony's Road, Leeds LS11 8DT, England.

P910023/S039

3/1/99

Cadence® Tiered Therapy Defibrillator System

St. Jude Medical, Inc.

Sunnyvale, CA

94086-6527

Approval to provide the standard Medic Alert® information with the Ventritex implantable cardiovertor defibrillators.

P910023/S040

3/26/99

Cadence® Tiered Therapy Defibrillator System and TVL® Leads System

St. Jude Medical

Sunnyvale, CA

94086-6527

Approval for a manufacturing site located at the St. Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.

P910061/S003

3/8/99

Soflex UV Absorbing Silicone Posterior Chamber IOLs

Bausch & Lomb Surgical

Clearwater, FL

33759

Approval for a manufacturings qualification protocol and a manufacturing site located at 21 Park Place Blvd., N., Clearwater, FL 33759.

P910061/S007

3/8/99

Soflex UV Absorbing Silicone Posterior Chamber IOLs

Bausch & Lomb Surgical

Clearwater, FL

33759

Approval for a manufacturings qualification protocol and a manufacturing site located at 21 Park Place Blvd., N., Clearwater, FL 33759.

P910061/S008*

3/15/99

Silicone Posterior Chamber Intraocular Lenses

Bausch & Lomb Surgical

Clearwater, FL

33759

Approval for minor revision to the labeling and an alternate sterilization method.

P910077/S027*

3/17/99

VENTAK® MINI III™ and MINI IV™ AICD™ Systems

Guidant Corporation

St. Paul, MN

55112-5798

Approval for a design and manufacturing change to the pulse generator hybrid assembly for the VENTAK® MINI III™ and MINI IV™ AICD™ Systems (Models 1782, 1783, 1786, 1788, 1789, 1790, 1792, 1793, and 1796.)

P920014/S008*

3/25/99

HeartMate® IP LVAS

Thermo Cardiosystems, Inc.

Woburn, MA

01888-2697

Approval to modify section 9.6 of the current directions for use to include instructions for adding an additional retaining suture from the Outflow Graft Screw Ring to the Outflow Elbow Screw Ring to secure the outflow graft and outflow conduit.

P920023/S007

3/29/99

UroLume® Endoprosthesis for Detrusor External Sphincter Dyssynergia

American Medical Systems

Minnetonka, MN

55343

The device is indicated for use in men to relieve urinary obstruction due to detrusor-external sphincter dyssynergia.

P920047/S012*

3/30/99

EPT-1000 Cardiac Ablation System

E.P. Technologies, Inc.

San Jose, CA

95134

Approval for a new technique for bonding the proximal to distal segment of catheters.

P940008/S012

3/31/99

Res-Q Micron Advantage ICD Models 101-10 and 101-10A

Intermedics, Inc.

Angleton, TX

77515-2523

Approval for suspension of the Res-Q Micron Advantage Models 101-10 and 101-10A postapproval study because of discontinuation of manufacturing and distribution of the device.

P940010/S006

3/4/99

OPTIGUIDE™ Cylindrical Fiber Optic (DCYL2 Diffuser Series)

QLT PhotoTherapeutics, Inc.

Washington, DC

20004-1109

Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).

P940019/S004

3/30/99

WALLSTENT® Iliac Endoprosthesis

Schneider (USA), Inc.

Pfizer Medical Technology Group

Minneapolis, MN

55442

Approval for labeling changes related to MRI claims.

P940022/S010

3/22/99

CLARION® Multi-Strategy Cochlear Implant (Adult) and (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.

P950018/S002*

3/5/99

Perfluoron™ (purified perfluoro-n-octane liquid)

Alcon Laboratories, Inc.

Fort Worth, TX

76134-2099

Approval for the following changes: use of an alternate Fluorotec S2-F451W stopper; changes in the aseptic filling and packaging processes to use the CBL Autobloc automated filling line; an alternate fill volume (2 ml) for Perfluoron in a unit package; a new Master Batch Record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.

P950019/S007*

3/19/99

Ray Threaded Fusion Cage (TFC)™ with instrumentation

United States Surgical Corporation

Norwalk, CT

06856

Approval for modified device outer box labels.

P950022/S005

3/26/99

Cadence® Tiered Therapy Defibrillator System and TVL® Leads System

St. Jude Medical

Sunnyvale, CA

94086-6527

Approval for a manufacturing site located at the St. Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.

P950034/S011*

3/11/99

Seprafilm™ Bioresorbable Membrane

Genzyme Corporation

Cambridge, MA

02139-1562

Approval for the extension of the expiration dating of Seprafilm™ Bioresorbable Membrane from 30 months to 36 months.

P960009/S004

3/25/99

Medtronic Activa Tremor Control System

Medtronic Neurological

Minneapolis, MN

55440

Approval for corrections to an educational brochure which contains instructions for routing and implantation of the lead to extension connection and the addition of a new warning label.

P960009/S006

3/25/99

Medtronic Activa Tremor Control System

Medtronic Neurological

Minneapolis, MN

55440

Approval for corrections to an educational brochure which contains instructions for routing and implantation of the lead to extension connection and the addition of a new warning label.

P960058/S009

3/22/99

CLARION® Multi-Strategy Cochlear Implant (Adult) and (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.

P970012/S008

3/12/99

Medtronic Kappa 400 Series Implantable Pulse Generators (Models KDR 401/403, KSR 401/403)

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for a manufacturing site located at Medtronic Europe S.A., Route de Molliau, Tolochenaz, Switzerland and a final packaging site located at Medtronic B.V., Kerkrade, Wenckebachstraat 10, 6466, Postbus, 1013-6460 BA, Kerkrade, The Netherlands.

P970024/S001

3/5/99

Lyra™ Implantable Cardioverter/

Defibrillator (ICD) System and AngePass™ Defibrillation Lead System

Angeion Corporation

Minneapolis, MN

55428-1088

Approval for the Lyra^TM ICD System (Models 2020, 2021, and 2022), Model 6200 Programmer Software, Smart Wand Programming Head Model 3009,

Angepass^TM RV Defibrillation Lead System (Model 4040, 4041, and 4042), and AngePass^TM SVC Defibrillation Lead System (Models 4080, 4081, and

4082). The devices as modified will be marketed under the trade names Lyra^TM and AngePass^TM, and are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced

one of the following situations: 1) Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular

tachyarrhythmia; and 2) Recurrent, poorly tolerated, sustained ventricular tachyarrhythmia.

P970044/S003

3/12/99

Urowave Microwave Thermotherapy System

Dornier Medical Systems, Inc.

Kennesaw, GA

30144

Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.

P980001/S004

3/10/99

NIR ON™ Ranger™ Premounted Stent System

Boston Scientific Corporation

Natick, MA

01760-1537

Approval for a change in the specification of the balloon component for the NIR ON™ Ranger™ Premounted Stent System. This change applies only to the 9 mm length NIR ON™ Ranger™ Premounted Stent System with the 3.0mm, 3.5mm and 4.0mm balloon diameters.

P980015/S002*

3/19/99

Sharpx Needle Destruction Unit

Biomedical Disposal, Inc.

Washington, D.C.

20006

Approval for the modifications of original device circuitry.

P980016/S004*

3/5/99

Model 6940 CapSureFix Lead

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for use of the Model 6940 CapSureFix Ventricular/Atrial Transvenous Lead. The device, as modified will be marketed under the trade name Model 6940 CapSureFix Lead and is intended for single long-term use in the right ventricle or right atrium for pacing and sensing.

P980017/S001

3/24/99

Possis Perma-Seal® Dialysis Access Graft, Model 2C20

Possis Medical, Inc.

Minneapolis, MN

55433-8003

Approval for extending the shelf life of the device from 3 to 6 years, and is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditions: 1) central v enous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.

APPLICATION NUMBER & LTR DATE

DEVICE NAME

COMMENTS

P960057/S005**

3/18/99

Adcon-L Adhesion Control in a Barrier Gel

Gliatech, Inc.

Cleveland, OH

44122

The 30-day Notice requested an eight-day holding period for filled syringes prior to sterilization.