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PMA Final Decisions Rendered for February 2000

2/3/000

AMOÒ SENSARÔ Soft Acrylic, UV Light-Absorbing, Posterior Chamber Intraocular Lens (IOL), Model AR40

Allergan, Inc.

Irvine, CA 92612-9534

Approval for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by extracapsular cataract extraction.

2/24/2000

CellugelÒ Ophthalmic Viscosurgical Device (OVD)

Alcon Laboratories

Fort Worth, Texas 76134

Approval for use during surgery in the anterior segment of the eye. It is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues and to manipulate tissues during surgery. It may also be used to coat intraocular lenses and other instruments during cataract extraction and IOL insertion.

2/23/2000

TECHNOLASÒ 217A Excimer Laser System

Bausch & Lomb Surgical

Irvine, California 92618

Approval to perform Laser In-Situ Keratomileusis (LASIK): in treatments for the reduction or elimination of myopia (nearsightedness) from –1.00 to –7.00 diopters D with less than –3.00 D astigmatism; in patients with documented stability of refraction for the prior 12 months as demonstrated by a change in manifest refraction of less than or equal to 0.5 D (in both cylinder and sphere components); and in patients 21 years of age or older.

2/11/2000

Artegraft Bovine Heterograft

Artegraft, Inc.

Approval for a manufacturing site located at Artegraft, Inc., 220 North Center Drive, North Brunswick, NJ.

2/28/2000

AviteneÔ

Microfibrillar Collagen Hemostat (MCH)

Davol, Inc.

Subsidiary of C.R. Bard, Inc.

Woburn, Massachusetts 01801

Approval to market a product line extension, i.e., Avitene UltraFoam Microfibrillar Collagen Hemostat (MCH) Sponge.

2/1/2000

Vitekâ 2 Gram Negative Susceptibility Test for Ticarcillin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic ticarcillin at concentrations of 16, 32 and 64 m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organism to ticarcillin in the range of <8 to >128m g/ml.

2/8/2000

Vitekâ 2 Gram Positive Susceptibility Test for High-Level Streptomycin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic streptomycin at a concentration of 1000 m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System.

2/7/2000

Vitekâ 2 Gram Negative Susceptibility Test for Norfloxacin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic norfloxacin at concentrations of 1, 8 and 32m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organism to norfloxacin in the range of <0.5 to >16m g/ml.

2/8/2000

Vitekâ 2 Gram Negative Susceptibility Test for Tetracycline

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic tetracycline at concentrations of 2, 4, and 8m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to tetracycline in the range of <1 to >16m g/ml.

2/8/2000

Vitekâ 2 Gram Positive Susceptibility Test for Nitrofurantoin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32 and 64 m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organisms to nitrofurantoin in the range of <16 to >512m g/ml.

2/15/2000

Vitekâ 2 Gram Positive Susceptibility Test for Oxacillin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic oxacillin at concentrations of 0.5, 1 and 2m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organisms to oxacillin in the range of <0.25 to >4m g/ml.

2/10/2000

Vitekâ 2 Gram Negative Susceptibility Test for Cefoxitin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic cefoxitin at concentrations of 8, 16, and 32m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organisms to cefoxitin in the range of <4 to >64m g/ml.

2/17/2000

Vitekâ 2 Gram Negative Susceptibility Test for Piperacillin/

Tazobactam

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic piperacillin/ tazobactam at concentrations of 4/4, 16/4, and 128/4m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organisms to piperacillin/ taxobactam in the range of <4/4 to >128/4m g/ml.

2/17/2000

Vitekâ 2 Gram Negative Susceptibility Test for Cefpodoxime

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic cefpodoxime at concentrations of 0.5, 1, and 4 m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organisms to cefpodoxime in the range of <0.25 to >8m g/ml.

2/28/2000

St. Jude Medical Mechanical Heart Valve

St. Jude Medical, Inc.

St. Paul, MN 55117

Approval which describes a validation for a sterilization change.

2/16/2000

ACS RX Solaris and ACS OTW Solaris Coronary Dilatation Catheters

Vascular Intervention Group

Temecula, CA 92589-9018

Approval for a revision to the Instructions for Use booklet for ACS RX SOLARISÔ and ACS OTW SOLARISÔ Coronary Dilatation Catheters to include the addition of the ACS Multi-Link TristarÔ Stent to sections pertaining to post-implant stent dilatation.

2/23/2000

VENTAKÒ Implantable Cardioverter Defibrillator System ENDOTAKÒ Transvenous Defibrillation Lead System, ThinLineÔ and FINELINE Transvenous Endocardial Pacing Leads

Guidant Corp.

St. Paul, MN 55112-5798

Approval for: a) all previously marketed Intermedics stylets kits to be marketed under new Guidant model numbers 6032-6066, 6765-6770, 6826, 6828, 6963, 6964, 6971, 6972, 6983, and 6985, and b) an alternate stylet kit package insert. These devices are indicated for aiding in the introduction of pacing and defibrillator leads.

2/24/2000

Access Hybritech PSA Assay

Beckman Coulter, Inc.

Chaska, Minnesota 55318

Approval for addition of the Access Hybritech PSA Assay on the Access Immunoassay analyzer to other approved instrument platforms. The AccessÒ HybritechÒ PSA assay is a paramagnetic particle, chemiluminiscent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum, using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

2/1/2000

MAXXUMÔ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Scimed Life Systems, Inc.

Maple Grove, MN 55311-1566

Approval for an additional indication for the MAXXUMÔ PTCA Catheter(balloon diameters ranging from 2.5-4.0 mm in 0.25mm increments with balloon lengths of 13, 20 and 29 mm), the post-delivery expansion of balloon expandable stents.

2/23/2000

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters

Boston

Scientific/SCIMED

Maple Grove, MN 5311-1566

Approval for use of an alternative catheter packaging configuration.

2/25/2000

Medstone STS-T Lithotripter

Medstone International, Inc.

Aliso Viejo, California 92656

Approval for 1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and 2) the addition of protective covers for the U-arms’ electrical connections.

2/22/2000

Exogen 2000Ò or Sonic Accelerated Fracture Healing System (SAFHSÒ )

Exogen, Inc.

Piscataway, New Jersey 08855

Approval for the non-invasive treatment of established nonunions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

2/1/2000

PALMAZ-SCHATZÔ MiniCrown Balloon-Expandable Stent with HepacoatÔ on DynastyÔ Over the Wire Delivery System

Cordis Corporation

Warren, NJ 07059

Approval for the addition of a heparin coating on the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent on DynastyÔ Over the Wire Delivery System.

2/25/2000

CrossFlexÔ LC Balloon Expandable Stent with Over-the-Wire Delivery System

Cordis Corporation

Warren, NJ 07059

Approval for a 5-year post-approval study protocol for the CrossFlexÔ LC Balloon Expandable Stent with Over-the-Wire Delivery System.

2/4/2000

PALMAZ-SCHATZÔ Crown Balloon Expandable Stend with PowerGripÔ Over-the-Wire Delivery System

Cordis Corp.

Warren, NJ 07059

Approval for 1)the addition of a note in the Instructions for Use regarding correct prepping procedures for the balloon, 2)the addition of new width and height specifications for the inflation lumen tubing, and 3) the addition of an automated deflation test prior to product release.

2/16/2000

RotablatorÒ Rotational Angioplasty System

Boston Scientific Corporated Northwest Technology Center, Inc.

Redmond, WA 98052-3376

Approval for the addition of a ground test to the calibration and final test procedure for the RotablatorÒ console.

2/23/2000

VENTAKÒ Implantable Cardioverter Defibrillator System ENDOTAKÒ Transvenous Defibrillation Lead System, ThinLineÔ and FINELINE Transvenous Endocardial Pacing Leads

Guidant Corp.

St. Paul, MN 55112-5798

Approval for: a) all previously marketed Intermedics stylets kits to be marketed under new Guidant model numbers 6032-6066, 6765-6770, 6826, 6828, 6963, 6964, 6971, 6972, 6983, and 6985, and b) an alternate stylet kit package insert. These devices are indicated for aiding in the introduction of pacing and defibrillator leads

2/14/2000

UroLumeÒ

Endoprosthesis

American Medical Systems, Inc.

Minnetonka, MN 55343

Approval to extend the shelf life expiration dating up to 5 years.

2/9/2000

AMS UroLumeÒ Endoprosthesis for Recurrent Bulbar Urethral Strictures, Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy, and Detrusor External Sphincter Dyssynergia

American Medical Systems

Minnetonka, Minnesota 55343

Approval for modification of the delivery tool handle.

2/2/2000

Micro-PaceÔ Dual-Chamber Pulse Generator, Model 4553

Pace Medical, Inc.

Waltham, Massachusetts 02154

Approval for an alternate vendor located at Princeton Technology, Inc., 12 Park Avenue, Hudson, New Hampshire 03051.

2/3/2000

SVS Apex PlusÒ Excimer Laser Workstation

Summit Technology, Inc.

Waltham, MA 02154

Approval of name change. The device, as modified, will be marketed under the trade name Infinity LSÔ Excimer Laser System.

2/2/2000

CLARIONÒ Multi-Strategy Cochlear Implant (Adult)

Advanced Bionics Corp.

Sylmar, CA 91342

Approval for the size reduction in the speech processor known as the Platinum Sound Processor.

2/25/2000

Model 6698 Patient Test Magnet

Guidant, Cardiac Rhythm Management

St. Paul, MN 55112-5798

Approval for the Model 6698 Patient Test Magnet.

2/1/2000

CelsiusÔ Diagnostic/Ablation Deflectable Braided Tip Catheter Interface Autoclavable Cables (Models D-1170-01 and D-1170-05)

Cordis Webster, Inc.

Diamond Bar, CA 91765

Approval for autoclavable interface cables for use with the CelsiusÔ Diagnostic/Ablation Deflectable Braided Tip Catheters.

2/23/2000

VENTAKÒ Implantable Cardioverter Defibrillator System ENDOTAKÒ Transvenous Defibrillation Lead System, ThinLineÔ and FINELINE Transvenous Endocardial Pacing Leads

Guidant Corp.

St. Paul, MN 55112-5798

Approval for: a) all previously marketed Intermedics stylets kits to be marketed under new Guidant model numbers 6032-6066, 6765-6770, 6826, 6828, 6963, 6964, 6971, 6972, 6983, and 6985, and b) an alternate stylet kit package insert. These devices are indicated for aiding in the introduction of pacing and defibrillator leads

2/7/2000

Heparin Surface Modified (HSM) Polymethylmethacry-late (PMMA) Posterior Chamber Intraocular Lenses

Pharmacia & Upjohn Company

Pickerington, OH 43147

Approval to manufacture the HSM PMMA posterior chamber intraocular lenses using UVEX 326 PMMA.

2/2/2000

CLARIONÒ Multi-Strategy Cochlear Implant (Pediatric)

Advanced Bionics Corp.

Sylmar, CA 91342

Approval for the size reduction in the speech processor known as the Platinum Sound Processor.

2/16/2000

NeuroCybernetic Prosthesis (NCPÒ ) System

Cyberonics, Inc.

Houston, TX 77058

Approval for changes to the approved patient labeling for the NCP System.

2/29/2000

MedtronicÒ

InterstimÒ System for Urinary Control

Medtronic, Inc.

Minneapolis, MN 55421

Approval for a quick guide to the Model 3031 Patient Programmer that will be provided to implanting physicians for distribution to both currently implanted and future patients.

2/23/2000

Medtronic FreestyleÒ Aortic Root Bioprosthesis, Model 995

Medtronic Heart Valves

Santa Ana, CA 92705

Approval for a pre-trimmed subcoronary configuration, Model 995CS.

2/24/2000

Access Hybritech free PSA assay

Beckman Coulter, Inc.

Chaska, MN 55318

Approval for the addition of the Access Hybritech free PSA on the Access Immunoassay analyzer to other approved instrument platforms. The device, as modified, will be marketed under the trade name Access Hybritech free PSA assay and is indicated for use as follows: The AccessÒ HybritechÒ free PSA is a paramagnetic particle, chemiluminiscent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA, as measuered by the Hybritech assays, is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.

2/11/2000

RADIUSÔ Coronary Stent with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN 55311-1566

Approval for the addition of two tensile strength specifications for the pullwire assembly.

2/8/2000

SURGIFOAMÒ

Absorbable Gelatin Sponge, USP

Ethicon, Inc.

Somerville, New Jersey 08876-0151

Approval for a change in the "Indications for Use" statement. This changed requested the removal of neurosurgery form the exclusions.

2/9/2000

HyskonÒ

Hysteroscopy Fluid

CooperSurgical, Inc.

Huntington, CT 06484

Requested provision for the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility.

2/18/2000

Bradycardia Pulse Generators

St. Jude Medical

Sylmar, CA 91342

Requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.

2/4/00

Boston Equalens (Itafluoprofocon A) and Equalens II (Oprifocon A) Rigid Gas Permeable Contact Lens

Polymer Technology

Rochester, NY 14692

Approval for addition of one finishing laboratory, Procornea Nederland BV, Kollergan 9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distribution site for the referenced devices.

2/18/2000

Bradycardia Pulse Generators

St. Jude Medical

Sylmar, CA 91342

Requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.

2/11/2000

Rotoblator Rotational Angioplasty System

Boston Scientific Corp.

Redmond, WA 98052-1600

Requested the addition of an inspection of the advancer short drive shaft following the wet test.

3/18/2000

Bradycardia Pulse Generators

St. Jude Medical

Sylmar, CA 91342

Requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.

2/25/2000

NIRÔ Premounted Stent Systems

Boston Scientific Corporation A285

Maple Grove, Minnesota 55311

Requested a change to increase the tolerance allowed in the stent overlap to markerband placement by 0.25mm (from 0.25 mm to 0.50mm).

2//8/2000

The AneuRxÔ Stent Graft System

Medtronic AVE Peripheral Technologies

Santa Rosa, CA 95407

Requested changes to eliminate a final cleaning step and to add a supplier of Nitinol tubing and as-cut stents.

2//8/2000

The AneuRxÔ Stent Graft System

Medtronic AVE Peripheral Technologies

Santa Rosa, CA 95407

Requested changes to eliminate a final cleaning step and to add a supplier of Nitinol tubing and as-cut stents.