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PMA Final Decisions Rendered for July 2002

P000058

7/2/02

InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for the InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device. This device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit and/or neurological deficit and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. InFUSE™ Bone Graft/LT-CAGE™ devices are to be implanted via an anterior open or an anterior laparoscopic approach. Patients receiving the InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the InFUSE™ Bone Graft/LT-CAGE™ Device.

P010039

7/19/02

Siemens SONOCUR® Basic

Siemens Medical Solutions USA, Inc.

Iselin, NJ

08830

Approval for the Siemens SONOCUR Basic. The Siemens SONOCUR Basic is a non-surgical alternative for the treatment of chronic lateral epicondylitis (commonly referred to as tennis elbow) for patients with symptoms of chronic lateral epicondylitis for 6 months or more and a history of unsuccessful conservative treatments.

P010050

7/26/02

IMMULITE® HBsAg, IMMULITE® 2000 HBsAg and IMMULITE® HBsAg Confirmatory Kit

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for the IMMULITE® HBsAg, IMMULITE® 2000 HBsAg and IMMULITE® HBsAg Confirmatory Kit. These devices are indicated for:
IMMULITE HBsAg: IMMULITE HBsAg is a solid-phased chemiluminescent enzyme immunoassay designed for in vitro use with the IMMULITE automated immunoassay analyzer for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis B virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at high risk of acquiring HBV during the perinatal period.
IMMULITE® 2000 HBsAg: IMMULITE 2000 HBsAg is a solid-phase chemiluminescent enzyme immunoassay designed for in vitro use with the IMMULITE 2000 automated immunoassay analyzer for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis B virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at high risk of acquiring HBV during the perinatal period.
IMMULITE HBsAg Confirmatory Kit: IMMULITE HBsAg Confirmatory is intended for in vitro diagnostic use in conjunction with the IMMULITE HBsAg or the IMMULITE 2000 HBsAg assays for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, heparinized, citrate) that were repeatedly positive when tested by IMMULITE or IMMULITE 2000 HBsAg.

P010051

7/24/02

IMMULITE® Anti-HBc and IMMULITE® 2000 Anti-HBc

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for the IMMULITE® Anti-HBc and IMMULITE® 2000 Anti-HBc. These devices are indicated for:
IMMULITE® Anti-HBc: IMMULITE Anti-HBc is a solid –phase chemiluminescent enzyme immunoassay designed for use on the IMMULITE automated immunoassay analyzer for the qualitative detection of total antibodies against hepatitis B core antigen (Anti-HBc) in human serum or plasma (EDTA, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of ongoing or previous hepatitis B virus infection. IMMULITE® 2000 Anti-HBc: IMMULITE 2000 Anti-HBc is a solid-phase chemiluminescent enzyme immunoassay designed for use on the IMMULITE 2000 automated immunoassay analyzer for the qualitative detection of total antibodies against hepatitis B core antigen (anti-HBc) in human serum or plasma (EDTA, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of ongoing or previous hepatitis B virus infection.

P010052

7/22/02

IMMULITE® Anti-HBs and IMMULITE® 2000 Anti-HBs

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for the IMMULITE® Anti-HBs and IMMULITE® 2000 Anti-HBs. The devices are indicated for:
IMMULITE® ANTI-HBs: For in vitro diagnostic use with the IMMULITE automated immunoassay analyzer for the qualitative measurement of total antibodies to the hepatitis B surface antigen (anti-HBs) in human serum and plasma (heparinized or EDTA). Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection.
IMMULITE® 2000 Anti-HBs: For in vitro diagnostic use with the IMMULITE 2000 automated immunoassay analyzer for the qualitative measurement of total antibodies to the hepatitis B surface antigen (anti-HBs) in human serum and plasma (heparinized or EDTA). Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection.

P010053

7/26/02

IMMULITE® Anti-HBc IgM and IMMULITE® 2000 Anti-HBc IgM

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for the IMMULITE® Anti-HBc IgM and IMMULITE® 2000 Anti-HBc IgM. These devices are indicated for: IMMULITE® Anti-HBc IgM: IMMULITE Anti-HBc IgM is a solid-phase chemiluminescent enzyme immunoassay designed for use with the IMMULITE automated immunoassay analyzer for the qualitative measurement of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (EDTA, heparinized or citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis B viral infection. IMMULITE® 2000 Anti-HBc IgM: IMMULITE 2000 Anti-HBc IgM is a solid-phase chemiluminescent enzyme immunoassay designed for use with the IMMULITE 2000 automated immunoassay analyzer for the qualitative measurement if IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (EDTA, heparinized or citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis B viral infection.

P020003

7/19/02

Mentor Saline-Filled Testicular Prosthesis

Mentor Corporation

Santa Barbara, CA

93111

Approval for the Mentor Saline-Filled Testicular Prosthesis. The device is indicated for use when cosmetic testicular replacement is indicated; i.e., in the case of agenesis or following the surgical removal of a testicle.

P810025/S020

7/19/02

180-Day

Amvisc™ and Amvisc™ Plus Sodium Hyaluronate

Bausch & Lomb

San Dimas, CA

91773

Approval for a new aseptic manufacturing suite located at Anika Therapeutics, Inc., Woburn, Massachusetts.

P810031/S024

7/25/02

180-Day

Healon®5 Sodium Hyaluronate

Pharmacia & Upjohn

Kalamazoo, MI

49001

Approval for modification of the "Precaution" section of the package insert to include the following: "Before initiating phacoemulsifica-tion, use irrigation/ aspiration to create a fluid-filled space above the lens. This reduces the risk of initial visco-occulsion of the phaco tip or the irrigation line which could cause phaco tip heating."

P830045/S081

7/30/02

Real-Time

St. Jude Medical Epic™ VR/DR Implantable Cardioverter Defibrillators (Models V-197 and V-235)

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for a downsized version of the Photon µDR/VR device. The device, as modified, will be marketed under the trade name St. Jude Medical Epic™ VR/DR Implantable Cardioverter Defibrillators (Models V-197 and V235) and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P830061/S034

7/23/02

180-Day

CapSure Sense Lead Models 4074, 4574, 4073 and Vitatron Crystalline Lead Models ICM09B, ICM09JB, and ICM09

Medtronic, Inc.

Minneapolis, MN

55432

Approval for pacing leads that incorporate a new surface coating, a new electrode geometry, a new combination of previously used steroids, and a new tapered stylet. The device, as modified, will be marketed under the trade names CapSure Sense Lead Models 4074/4574/4073 and the Vitatron Crystalline Lead Models ICM09B, ICM09JB, and ICM09. These devices are indicated for pacing or sensing in the atrium or ventricle. The leads have application where implantable atrial or ventricular single-chamber or dual-chamber pacing systems are indicated.

P840001/S062

7/25/02

Real-Time

Medtronic Itrel® Spinal Cord Stimulation System

Medtronic Neurological

Minneapolis, MN

55432

Approval for the Model 3550-16 EZ Anchor Accessory Kit which will be labeled for use with the following Medtronic, Inc. leads: Pisces-Quad® Model 3487A, RESUME® Model 3587A, Temporary Screening Lead Model 3861, Pisces-Quad® Compact Model 3887, Pisces-Quad® Plus Model 3888 and the Pisces-Octad® Model 3898. The Model 3550-16 EZ Anchor is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.

P880086/S088

7/30/02

Real-Time

St. Jude Medical Epic™ VR/DR Implantable Cardioverter Defibrillators (Models V-197 and V-235)

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for a downsized version of the Photon µDR/VR device. The device, as modified, will be marketed under the trade name St. Jude Medical Epic™ VR/DR Implantable Cardioverter Defibrillators (Models V-197 and V235) and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P890017/S010

7/10/02

180-Day

Cordis PALMAZ® Balloon Expandable Stent (Models P104R, P154R, P204R)

Cordis Corporation

Warren, NJ

07059

Approval for the Cordis PALMAZ Balloon Expandable Stent (Models P104R, P154R, P204R). The device is indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous renal angioplasty (PTRA) of a de novo or restenotic lesion (≤22 mm in length) located within 10 mm of the aortorenal artery border and with a reference vessel diameter of ≥ 4 mm and ≤ 8 mm. Suboptimal PTRA results are defined by one or more of the following unfavorable results: ≥ 50% residual stenosis by visual estimate, ≥ 20 mm Hg peak translesional pressure gradient, ≥ 10 mm Hg mean translesional pressure gradient, and/or Grade D dissection (a spiral shaped filling defect within the lumen of the vessel) or any dissection with significant compromise in lumen flow.

P900039/S011

7/2/02

180-Day

Collagraft Strip Bone Graft Matrix

NeuColl, Inc.

Campbell, CA

95008

Approval for addition manufacturing sites located at: Bioserv Corporation, San Diego, California; Biological Test Center, B. Braun Medical, Inc., Irvine, California; NeuColl, Inc., Cambell, California; and Pharmaceutical Systems, Inc., Mundalein, Illinois.

P910023/S061

7/30/02

Real-Time

St. Jude Medical Epic™ VR/DR Implantable Cardioverter Defibrillators (Models V-197 and V-235)

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for a downsized version of the Photon µDR/VR device. The device, as modified, will be marketed under the trade name St. Jude Medical Epic™ VR/DR Implantable Cardioverter Defibrillators (Models V-197 and V235) and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P910073/S039

7/25/02

180-Day

ENDOTAK RELIANCE and RELIANCE/S Steroid Eluting Extendable/

Retractable Helix Endocardial Defibrillation Lead Models 0137, 0138, 0139, 0157, 0158, and 0159

Guidant Corporation

St. Paul, MN

55112

Approval for modified active fixation defibrillation leads. The device, as modified, will be marketed under the trade names ENDOTAK RELIANCE and RELIANCE/S Leads and is indicated for pacing and rate-sensing and to deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator systems.

P910077/S037

7/18/02

Panel

Ventak Prizm 2 VR/DR Models 1860/1861, Ventak Prizm VR/DR Models 1850/1851/1855/

1856, Ventak Prizm VR/DR HE Models 1852/1853, Ventak Mini IV Models 1790/1793/1796 and Ventak Mini III HE Model 1789.

Guidant Corporation

St. Paul, MN

55112

Approval for the Ventak Prizm 2 VR/DR Models 1860/1861, Ventak Prizm VR/DR Models 1850/1851/1855/

1856, Ventak Prizm VR/DR HE Models 1852/1853, Ventak Mini IV Models 1790/1793/1796 and Ventak Mini III HE Model 1789. These devices are indicated in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias. In addition, these devices are indicated for prophylactic treatment of patients with a prior myocardial infarction and an ejection fraction (EF) ≤30% (as defined in the Clinical Study section).

P920031/S003

7/24/02

180-Day

COBAS INTEGRA 400 PLUS Cyclosporine

Dade Behring, Inc.

Newark, DE

19714

Approval for expanding the use of the COBAS INTEGRA Cyclosporine Reagent to the COBAS INTEGRA 400 PLUS Analyzer. The device, as modified, will be marketed under the trade name COBAS INTEGRA Cyclosporine and is indicated for quantitative determination of Cyclosporine in whole blood as an aid in the management of Cyclosporine therapy in kidney, heart and liver transplant patients.

P950018/S008

7/29/02

Real-Time

Perfluoron™ (purified perfluoro-n-octane liquid)

Alcon Research, Ltd.

Fort Worth, TX

76134

Approval for adding blister packaging to the vial product that is then subjected to a steam sterilization process in order to provide a finished product vial with a sterile exterior. Also, approval of a 10 ml vial for the 7 ml fill product to allow sterilization headspace.

P950020/S005

7/17/02

180-Day

6 mm Cutting Balloon™

Boston Scientific Interventional Technologies

San Diego, CA

92123

Approval for the 6 mm Cutting Balloon™. The device, as modified, will be marketed under the trade name Cutting Balloon™ Monorail/OTW (6 mm) and is indicated for dilatation of stenosis in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: discrete (≤ 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45 degrees), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.

P950032/S032

7/2/02

Real-Time

Apligraf

Organogenesis, Inc.

Canton, MA

02021

Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 012).

P960009/S024

7/29/02

Real-Time

Medtronic Access Review™ Model 7438 Therapy Controller

Medtronic Neurological

Minneapolis, MN

55421

Approval for minor changes to the labeling of the existing Medtronic Access Review™ Model 7438 Therapy Controller to be used with Medtronic Activa® Parkinson’s Control System.

P960040/S026

7/18/02

Panel

Ventak Prizm 2 VR/DR Models 1860/1861, Ventak Prizm VR/DR Models 1850/1851/1855/

1856, Ventak Prizm VR/DR HE Models 1852/1853, Ventak Mini IV Models 1790/1793/1796 and Ventak Mini III HE Model 1789.

Guidant Corporation

St. Paul, MN

55112

Approval for the Ventak Prizm 2 VR/DR Models 1860/1861, Ventak Prizm VR/DR Models 1850/1851/1855/

1856, Ventak Prizm VR/DR HE Models 1852/1853, Ventak Mini IV Models 1790/1793/1796 and Ventak Mini III HE Model 1789. These devices are indicated in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias. In addition, these devices are indicated for prophylactic treatment of patients with a prior myocardial infarction and an ejection fraction (EF) ≤30% (as defined in the Clinical Study section).

P960052/S005

7/24/02

Special

Dermabond® Topical Skin Adhesive

Closure Medical Corporation

Raleigh, NC

27616

Approval for a change in indications to clarify the use of the device.

D970003/S017

7/2/02

Real-Time

INSIGNIA Entra and Plus Implantable Pacemaker Systems

Guidant Corporation

St. Paul, MN

55112

Approval for the modification to the INSIGNIA Entra and Plus Implantable Pacemaker Systems as follow:

1) Alternate accelerometer design; 2) A second source battery supplier for DDD and DDDR models; and 3) Revised mixed mode integrated circuit (MMIC) and digital integrated circuit (DIGIC) to improve manufacturability. The INSIGNIA I/Nexus I Entra and Plus pacemakers are indicated for treatment of the following: 1) Symptomatic paroxysmal or permanent second- or third-degree AV block: 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunction with or with-out associated AV conduction disorders (e.g., sinus bradycardia, sinus arrest, sinoatrial [SA] block); 4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and 5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in MV and/or level of physical activity (INSIGNIA I Plus only). The INSIGNIA I Entra and Plus pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of the following: 1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; and 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

P970003/S042

7/29/02

Real-Time

NeuroCybernetic Prosthesis (NCP®) System, Model 100/101 NCP Pulse Generator

Cyberonics, Inc.

Houston, TX

77058

Approval for minor labeling modifications to the existing Model 100/101 NCP Pulse Generator Physician’s Manual.

P980053/S004

7/30/02

180-Day

Durasphere™ Injectable Bulking Agent

Carbon Medical Technologies, Inc.

Saint Paul, MN

55110

Approval for the use of graphite bead substrate material as an alternate to zirconium oxide in the device.

P990015/S001

7/9/02

180-Day

Gynecare Intergel Adhesion Prevention Solution

Lifecore Biomedical, Inc.

Chaska, MN

55318

Approval for an additional manufacturing facility for the Blow/Fill/Seal and aseptic filling of the Gynecare Intergel Adhesion Prevention Solution. The facility is located at Cardinal Health Manufacturing Services, Automatic Liquid Packaging, Inc., Woodstock, Illinois.

P990017/S032

7/25/02

180-Day

ANCURE® ENDOGRAFT® System

Guidant Corporation

Menlo Park, CA

94025

Approval for the transfer of the jacket subassembly and parts washing to Guidant Puerto Rico, Dorado, Puerto Rico.

P990018/S002

7/12/02

Panel

Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens (for up to 30 days of extended wear)

Menicon Co., Ltd.

Nagoya, Japan

460-0006

Approval for the Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens. This device is indicated for: Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear. The lens may be disinfected using a chemical disinfection system only. (The Menicon Z™ (tisilfocon A) rigid gas permeable contact lens was cleared for daily wear under K962006, K970019 and K972443).

P990036/S003

7/25/02

Special

Cordis Checkmate System

Cordis Corp.

Miami, FL

33102

Approval for modifications to the Instructions for Use regarding the recoiling of the source ribbon on the spool of the delivery device and the use of the metal caps on the ends of the delivery device.

P990052/S008

7/2/02

180-Day

Vibrant® Soundbridge™ System

Symphonix Devices, Inc.

San Jose, CA

95131

Approval for changes to the manufacturing specification criteria for the Floating Mass Transducer™.

P990055/S004

7/19/02

180-Day

ACS:180 and Advia Centaur complexed PSA immunoassay

Bayer Corporation

Tarrytown, NY

10591

Approval for the adjustment of the calibration of the device.

P000011/S006

7/26/02

180-Day

BiodivYsio™ SV OTW

Abbott Vascular Devices

Redwood City, CA

94063

Approval for the addition of the 7 mm stent length (in all diameters, 2.0, 2.25 and 2.5 mm) and 2.25 mm diameter BiodivYsio™ SV OTW product to previously approved stent lengths of 10, 15 and 18 mm (Supplement 3). The device, as modified, will be marketed under the trade name BiodivYsio™ SV OTW and is indicated for: "improving coronary luminal diameter in subjects experiencing abrupt closure or threatened abrupt vessel closure following percutaneous revascularization of de novo or non in-stent restenotic native coronary artery lesions (length of lesion and/or dissection ≤25 mm) with reference vessel diameter ranging from ≥2.0 mm to ≤2.75 mm by visual estimate. Long-term outcome (beyond 6 months) for this implant is unknown at present.

P000025/S001

7/29/02

180-Day

Med-El COMBI 40+ Cochlear Implant System, C40+S (Compressed) Electrode Array and Med-El COMBI 40+ Cochlear Implant System, C40+ GB (Split) Electrode Array

Med-El Corporation

Durham, NC

27713

Approval for the Med-El COMBI 40+ Cochlear Implant System, C40+S (Compressed) Electrode Array and the Med-El COMBI 40+ Cochlear Implant System, C40+ GB (Split) Electrode Array.

P000025/S002

7/11/02

180-Day

Med-El COMBI 40+ Cochlear Implant System: CI.STUDIO+, Version 1.0 Software

Med-El Corporation

Durhan, NC

27713

Approval for the replacement of COMBI 40+ Cochlear Implant System DOS based software with CI.STUDIO+, Version 1.0 Software, for "remote consultative services".

P010003/S001

7/29/02

135-Day

BioGlue® Surgical Adhesive

Cryolife, Inc.

Kennesaw, GA

30144

Approval for

1) adding an additional vendor, Domnick Hunter, PLC, for the 0.2 µm-filter to filter bulk component solutions, and

2) adding a solution mixing system for the bovine serum albumin bulk solution for bags up to 20L in capacity.

P010019/S001

7/5/02

180-Day

Focus® Night and Day™ (lotrafilcon A) Soft Contact Lenses (extended wear for up to 30 nights of continuous wear)

Ciba Vision Corporation

Duluth, GA

30097

Approval for the revised post-approval study protocol for the device. The post-approval study protocol was submitted to comply with the conditions of approval outlined in the October 11, 2001 approval order for P010019.

P010032/S002

7/16/02

Real-Time

Genesis XP Neurostimulation System and Genesis XP Dual Neurostimulation System

Advanced Neuromodulation System, Inc.

Plano, TX

75024

Approval for the Genesis XP Neurostimulation System and Genesis XP Dual Neurostimulation System which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

P960036/S007

7/26/02

CV232 SRE™ Pre-rolled Acrylic Intraocular Lens

CIBA Vision Corporation

Duluth, GA

30097

Addition of an alternate steam sterilizer for the terminal sterilization of the CV232 SRE™ Pre-rolled Acrylic Intraocular Lens.

P970035/S040

7/24/02

Models S7, S670, and S660 Discrete Technology™ Over-The-Wire Coronary Stent System

Medtronic AVE

Santa Rosa, CA

95403

Change in the manufacturing process of applying the marker bands on the proximal tubing.

P970061/S016

7/31/02

Boston Scientific/SCIMED Radius Stent and Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change to use an alternate spray washer method for in-process Radius stent cleaning.

P990017/S034

7/24/02

ANCURE® ENDOGRAFT® System

Guidant Corporation

Menlo Park, CA

94025

Change to the manufacturing process for the ANCURE® ENDOGRAFT® System to add an inspection step in one manufacturing procedure for the contralateral pullwire.

P990026/S013

7/25/02

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Change in the Glucopad Assembly process in the AutoSensor Assembly sequence to increase the efficiency of the process.

P000018/S023

7/31/02

Novoste™ Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Change in the manufacturing process to implement a new process of applying the O-rings to the proprietary connector using an O-ring installation tool.