FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

PMA Final Decisions Rendered for November 2000

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

11/3/00

Cordis Checkmate®; System

Cordis Corporation

Miami, FL

33102

Approval for the Cordis Checkmate®; System. The device is indicated for the delivery of therapeutic doses of gamma radiation for the purpose of reducing in-stent restenosis. The system is for use in 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.

11/14/00

Optical Biopsy®; System

SpectraScience® Inc.

Minneapolis, MN

55447

Approval for the Optical Biopsy®; System. The device is indicated for use as an adjunct to lower gastrointestinal (GI) endoscopy. The device is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove. The device is only to be used in deciding whether such polyps should be removed (which includes submission for histological examination).

11/22/00

Elecsys® Total PSA Immunoassay and Elecsys® Total PSA Calset

Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for the Elecsys® Total PSA Immunoassay and Elecsys® Total PSA Calset. The device, a quantitative in vitro diagnostic test for total prostate-specific antigen (tPSA) in human serum and plasma is indicated for the measurement of total PSA in conjunction with digital rectal exam (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 prostate cancer. The test is further indicated for serial measurement of tPSA to aid in the management of prostate cancer patients. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 and 2010 immunoassay analyzers.

11/28/00

Ventana Medical Systems’ PATHWAY®; HER 2 (Clone CB11)

Ventana Medical Systems, Inc.

Tucson, AZ

85705

Approval for the PATHWAY®; HER 2 (Clone CB11). The device is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbB-2 antigen in sections of formalin fixed, paraffin embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is being considered.

11/3/00

Novoste Beta-Cath®; System

Novoste Corporation

Norcross, GA

30093

Approval for the Beta-Cath®; System. The device is indicated to deliver beta radiation to the site of successful Percutaneous Coronary Intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon) in a reference vessel diameter ranging from 2.7 mm to 4.0 mm.

11/29/00

Stinger®; Ablation Catheter and TempLink®; Extension Cable

C.R. Bard, Inc.

Lowell, MA

01851

Approval for the Stinger®; Ablation Catheter and TempLink®; Extension Cable. The device is indicated for creating focal endocardial lesions during cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.

PMA/PDP SUPPLEMENTAL APPROVALS

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

180-Day

St. Jude Medical Mechanical Heart Valve, Hemodynamic Plus Series, the Masters Series, and the CAVG/CAVGJ aortic valve grafts

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for a design change to the orifice graphite substrate.

180-Day

Healon®5 Sodium Hyaluronate Viscoelastic

Pharmacia & Upjohn

Kalamazoo, MI

49001

Approval for Healon®5 Sodium Hyaluronate Viscoelastic.

180-Day

FreshLook®; UV Spherical (phemfilcon A) Molded Soft (Hydrophilic) Contact Lens for Extended Wear

Wesley Jessen Corporation

Des Plaines, IL

60018

Approval for an alternate manufacturing facility located at Wesley Jessen PBH Limited, Southampton, United Kingdom.

Real-Time

Model 3510 Programmer and Software Model 3307 (V2.0)

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for Model 3510 Programmer and Software Model 3307 (V2.0).

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for design modifications to the LCS Rotating Patellar Bearing Replacement Component for the metal-backed 3-Peg Rotating Patella. The device, as modified, will be marketed as the Modified PFJ Rotating Patellar Bearing Replacement component.

Real-Time

LCS Total Knee System

DePuy Orthopaedic, Inc.

Warsaw, IN

46581

Approval for a change to the package insert regarding the indicated uses for the P.F.C. Sigma RP Curved tibial bearings. This change in indication would allow the P.F.C. Sigma RP Curved bearings to be used in posterior cruciate retaining procedures when used with the P.F.C. Sigma Cruciate Retaining Femoral Component.

Real-Time

Gambro Plasmafilter, PF2000N

GAMBRO Renal Products

Lakewood, CO

80215

Approval to 1) expand the instructions for use (IFUs) to permit the blood flow direction during use to be opposite to the direction of flow of the rinsing and priming solutions, and to 2) remove the blood flow direction arrow from the device label.

180-Day

UVAR Photopheresis Ssytem

Therakos, Inc.

Exton, PA

19341

Approval for a manufacturing facility located at Harmac Medical Products, Cheektowaga, New York.

180-Day

Thoratec Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval for a Surgical Implant Accessory Kit with the following accessories: Ventricular Cannula Venting Connector, Valve Housing Caps, Cannula Plugs, Atrial Cannula Tip Cap, and Y-Connector Cap. The Accessory Kit will be manufactured at Horizon Medical, Inc., Santa Ana, California, and sterilized by Sterigenics, Tustin, California.

180-Day

Thoratec Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval to use a hot melt adhesive at cable connection points within the uninterruptible power supply (UPS) battery pack assembly.

180-Day

Silicone Posterior Chamber Intraocular Lenses

Allergan, Inc.

Irvine, CA

92623

Approval for additional labeling statements.

Special

Affinity Family of Pulse Generators

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the addition of a layer of Kapton tape to the edge side of the devices’ battery case of the Affinity Family of Pulse Generators.

Real-Time

Model 3510 Programmer and Software Model 3307 (V2.0).

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for Model 3510 Programmer and Software Model 3307 (V2.0).

Real-Time

Model 3510 Programmer and Software Model 3307 (V2.0).

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for Model 3510 Programmer and Software Model 3307 (V2.0).

Real-Time

ENDOTAK® RELIANCE®; Models 147, 148, 149 and RELIANCE S®; Models 127, 128, 129 Endocardial Defibrillation Leads

Guidant Corporation

St. Paul, MN

55112

Approval for the lubricious coating, removal of one suture sleeve (on Models 127, 128, 147, 148), reduction of the yoke (on Models 147, 148, 149), and addition of the Puerto Rico facility for packaging, labeling, and sterilization.

180-Day

Atakr II Radiofrequency (RF) Generator – 60 Watts and Model 4806 Remote Control Foot Pedal/Switch with cable, Cable (#05116), Cable (#05228), Cable (#05328), Model 4807 Power Cord

Medtronic, Inc.

Minneapolis, MN

55432

Approval of a new RF Generator. The device, as modified, will be marketed under the trade name Atakr II and is indicated for interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia, treatment of AV nodal re-entrant tachycardia, and creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

180-Day

Angio-Seal®; Vascular Closure Device

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for an alternate manufacturing facility located at St. Jude Medical, Puerto Rico, Caguas, Puerto Rico.

Real-Time

Gen-Probe® Amplified Mycobacterium Tuberculosis Direct (MTD) Test

Gen-Probe, Inc.

San Diego, CA

92121

Approval for modification of the Enzyme Dilution Buffer and tentative reconstituted stability (pending completion of real-time studies) of the Enzyme Reagent for 30 days with an added precaution, and other minor changes to the labeling (including clarification of control testing procedures).

Real-Time

Cutting Balloon

Interventional Technologies, Inc.

San Diego, CA

92123

Approval for a modification to the distal tip of the Cutting Balloon®;.

180-Day

NeuroControl Freehand® System

NeuroControl Corporation

Valley View, OH

44125

Approval for: 1) Changing the manufacturing site for the Freehand Implantable Receiver-Stimulator to Lewicki Microelectronic, GmbH; 2) Addition of a radiographic identification label to the implantable receiver-stimulator; and 3) Implementing several design modifications involving the encapsulating material and circuitry of the Freehand Implantable Receiver-Stimulator.

180-Day

ThinLine®; II Sterox, Silicone, Passive-Fixation, Steroid Eluting Pacing Lead Model 430-25S; ThinLine®; II Sterox EZ, Silicone, Active-Fixation, Steroid Eluting Pacing Lead Model 438-25S; ThinLine®; II Sterox, Polyurethane, Passive-Fixation, Steroid Eluting Pacing Lead Models 430-35S and 432-35S; ThinLine®; II Sterox EZ, Polyurethane, Active-Fixation, Steroid Eluting Pacing Lead Model 438-35S; FINELINE®; II Sterox, Silicone, Passive-Fixation, Steroid Eluting Pacing Lead Models 4458 and 4459; FINELINE®; II Sterox EZ, Silicone, Active-Fixation, Steroid Eluting Pacing Lead Models 4472, 4473, and 4474; FINELINE®; II Sterox, Polyurethane, Passive-Fixation, Steroid Eluting Pacing Leads Models 4456, 4457, 4479, and 4480; FINELINE®; II Sterox EZ, Polyurethane, Passive-Fixation, Steroid

Eluting Pacing Leads Models 4469, 4470, and 4471

Guidant Corporation

St. Paul, MN

55112

Approval for the silicone and polyurethane ThinLine®; II Sterox and FINELINE®; II steroid eluting pacing leads. The devices are indicated for chronic pacing and sensing of the ventricle and/or atrium when used with a compatible pulse generator.

180-Day

Activa Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for an alternate manufacturing facility, for Model 3387 and Model 3389 DBS leads, located at Medtronic Neurological Puerto Rico, Villalba, Puerto Rico.

180-Day

CLARION® Multi-Strategy Cochlear Implant (Pediatric) HiFocus Electrode

Advanced Bionics® Corporation

Sylmar, CA

91342

Approval for the CLARION® Multi-Strategy Cochlear Implant HiFocus Electrode for pediatric use. The device, as modified, will be marketed under the trade name CLARION® Multi-Strategy Cochlear Implant (Pediatric) HiFocus Electrode and is indicated for severely and profoundly hearing impaired children ages 18 months to 17 years.

180-Day

Nucleus 24 Contour Cochlear Implant System – Adults and Children

Cochlear Corporation

Englewood, CO

80112

Approval for the modification of the electrode for the Nucleus CI24 Cochlear Implant. The device, as modified, will be marketed under the trade name Nucleus 24 Contour Cochlear Implant System with the following changes to the indications for use: 1) Approval to implant individuals, age 18 years and older, who obtain limited benefit from amplification as defined by test scores of £ 50% correct in the ear to be implanted, (£ 60% in the best aided listening condition) on tape recorded tests of open set sentence recognition. 2) Approval to implant children 12 months of age and older who have bilateral profound sensorineural hearing loss and obtain limited benefit from appropriately fitted hearing aids.

Real-Time

Medtronic GEM III DR Model 7275 ICD and Medtronic Model 9970 (GEM III DR) Programmer Application Software

Medtronic, Inc.

Shoreview, MN

55126

Approval for Medtronic GEM III DR Model 7275 ICD and Medtronic Model 9970 (GEM III DR) Programmer Application Software. The device, as modified, is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.

180-Day

Orchestra Programmer

ELA Medical, Inc.

Plymouth, MN

55441

Approval for Orchestra Programmer with the following application software packages: Manager software application version 1.02, CSO- A Programmer application version 2.21, DSP-Windows Programmer application version 1.02, Defender II programmer application version 2.03, and Defender IV programmer application version 1.03.

180-Day

Dema Pacing System

Vitatron, Inc.

Shoreview, MN

55126

Approval for the Dema Pacing System and the Vitatron Application Software Model VSA02, Version 6. The Dema Pacing System consists of the following pulse generators: Clarity DDR Models 860, 862, 865; Clarity SSIR Models 560, 562, 565; Diamond 3 Model 840; Ruby 3 Model 740; Topaz 3 model 540; Jade 3 Model 340; Vita 2 DDR Model 830; Vita 2 Model 530.

Real-Time

Surgifoam Absorbable Gelatin Sponge, USP

Ethicon, Inc.

Somerville, NJ

08876

Approval for a new configuration (Hemorrhoidectomy Sponge) of the Absorbable Gelatin Sponge, USP as well as a new bubble wrap package, a change in the sterilization procedure and some minor changes to the package labeling. The device, as modified, will be marketed under the trade name Surgifoam® Absorbable Gelatin Sponge, USP, Hemorrhoidectomy Sponge and is indicated for surgical procedures (except urologic and ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.

180-Day

ANCURE® ENDOGRAFT® System

Guidant Corporation

Menlo Park, CA

94205

Approval for the addition of a coating to the inferior (tube only) and superior capsules (all configurations) of the ANCURE® delivery catheters.

Real-Time

Medtronic® IsoMed® Constant Flow Infusion System Model 8472 IsoMed® Implantable Constant Flow-Infusion Pump

Medtronic, Inc.

Shoreview, MN

55126

Approval for the following modifications to the Model 8472 pump: 1) modification of the mounting of the bellows infusate reservoir; 2) slight changes in the configuration of five component parts in order to maintain the heights of the pumps following the change in mounting; and 3) required changes in five welds to facilitate the previously stated modifications.

180-Day

Senographe 2000D (Full Field Digital Mammography System)

GE Medical Systems

Milwaukee, WI

53201

Approval for use of the Review Workstation for final interpretation of examinations.

11/9/00

Medtronic Hall Prosthetic Heart Valve, Model A7700, Sizes 20 mm, 22 mm, and 24 mm

Medtronic Heart Valves

Santa Ana, CA

92705

Alternate supplier for the polytetrafluoroethylene (PTFE) fabric constructed of PTFE yarn. This fabric is used to manufacture the sewing ring component for the Medtronic Hall Prosthetic Heart Valve, Model A7700, sizes 20, 22 and 24 mm.

11/3/00

CrossSail®; Coronary Dilatation Catheter

Guidant Corporation

Temecula, CA

92591

Modifications as follows: 1) modify the troubleshooting process describing how to release the tubing from a mold; 2) modify the set-up/cleaning process prior to joining the device at the mod-lap joint; 3) modify the set-up process prior to plasma treating the device.

11/8/00

NIR®

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Manufacturing change to include the use of scrapped material in final functional testing to obtain trending data for SOX securement.

11/1/00

Durasphere Injectable Bulking Agent®

Advanced UroScience

Saint Paul, MN

55110

Addition of an alternate subcontractor to heat-seal the tray lid package for the Durasphere Injectable Bulking Agent® and an alternate supplier for Tyvec 1078B lid for use by the alternate subcontractor.