P980033

11/16/01

WALLSTENT® Venous Endoprosthesis with Unistep™ Plus RP Delivery System (10 mm Venous Endoprosthesis) and WALLSTENT® Venous Endoprosthesis with Unistep™ Plus Delivery System (12 mm – 16 mm Venous Endoprostheses

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for the WALLSTENT® Venous Endoprosthesis with Unistep™ Plus RP Delivery System (10 mm Venous Endoprosthesis) and the WALLSTENT® Venous Endoprosthesis with Unistep™ Plus Delivery System (12 mm – 16 mm Venous Endoprostheses).  These devices are indicated for improving central venous luminal diameter following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract.  Unsuccessful angioplasty is defined as residual stenosis >=30 percent for a vein <= 10 mm in diameter or >=50 percent for a vein > 10 mm in diameter, a tear which interrupts the integrity of the intima or lumen, abrupt lesion site occlusion, or refractory spasm.  The vessels that can be treated with the device are the innominate and subclavian veins ranging from 8 mm to 15 mm in diameter.

P990015

11/16/01

GYNECARE INTERGEL Adhesion Prevention Solution

Lifecore Biomedical, Inc.

Chaska, MN

55318

Approval for the GYNECARE INTERGEL Adhesion Prevention Solution.  The device is indicated for use in patients undergoing open, conservative gynecologic surgery as an adjunct to good surgical technique to reduce post-surgical adhesions.  GYNECARE INTERGEL Adhesion Prevention Solution is also intended to reduce the likelihood of developing moderate or severe postoperative adnexal adhesions in these patients.

P000052

11/2/01

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for the GALILEO™ Intravascular Radiotherapy System which consists of the GALILEO™ Source Delivery Unit, 27 mm GALILEO™ Centering Catheter, and 27 mm 32P Source Wire.  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 <= 47 mm in reference vessel diameter 2.4 mm to 3.7 mm.

P000057

11/19/01

Ascension MCP

Ascension Orthopedics, Inc.

Austin, TX

78754

Approval for the Ascension MCP.  The device is indicated for use as a total joint replacement of index, long, ring, and small finger metacarpophalan-geal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/ dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization.

P010007

11/9/01

IMMULITE® AFP and IMMULITE 2000® AFP

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for IMMULITE® AFP for use with the IMMULITE Analyzer  and IMMULITE 2000® AFP for use with the IMMULITE 2000 Analyzer.  These devices are indicated for in vitro diagnostic use for the quantitative measurement of alpha-fetoprotein (AFP) in either of two contexts:  A)  serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer: or  B) measurement in maternal serum and amniotic fluid during gestational weeks 15 through 20 – used in conjunction with ultrasonography or amniography – to aid in detection of fetal open neural tube defects.

P010027

11/21/01

Allergan, Inc. Model AC21B Ultraviolet-Absorbing PMMA Anterior Chamber Intraocular Lens.

Ophthalmic Innovations International, Inc.

Ontario, CA

91761

Approval for the Allergan, Inc. Model AC21B Ultraviolet-Absorbing PMMA Anterior Chamber Intraocular Lens, available in three overall diameters (12.0 mm, 13.0 mm, 14.0 mm).  The application is a licensing PMA in which Allergan, Inc. has giving Ophthalmic Innovations International, Inc. reference rights to P860034.  Additionally, it is requested that Allergan, Inc. distribute the lens as the DuraLens™ II Model AC21B.  The device is indicated for the replacement of the human lens in the visual correction of aphakia.  The anterior chamber intraocular lens is to be used in patients 60 years of age and older where a cataractous lens has been removed by primary intracapsular cataract extraction (ICCE); or by primary extracapsular cataract extraction (ECCE) where there is a structural reason that the anterior chamber lens is the preferred one; or other primary ECCE provided that this be performed only after the physician has compared the published results of the anterior chamber lens with posterior chamber lenses; or in a secondary implant procedure.

P010032

11/21/01

Genesis Neurostimulation (IPG) System

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for the Genesis Neurostimulation (IPG) System.  The System includes the following components: the Model 3608 pulse generator, the Model 3850 patient programmer, the Model 1232 programming wand and the Model 1210 patient magnet.  The device is 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.

P010033

11/28/01

QuantiFERON®-TB

Cellestis Limited

St. Kilda, Victoria, Australia

3182

Approval for the Cellestis QuantiFERON®-TB.  The device is indicated for use as an aid in the detection of infection with mycobacterium tuberculosis.

N16420/S006

11/21/01

180-Day

Mentor Polytef Paste for Injection

Mentor Corporation

Santa Barbara, CA

93111

Approval for relocation of the formulation of the bulk past and the equipment and processes associated with compounding to Mentor, Minneapolis, MN.

P780010/S022

11/16/01

180-Day

Permalens (perfilcon A) Soft (hydrophilic) Contact Lenses

CooperVision

Scottsville, NY

14546

Approval for a change in initiator for the referenced devices manufactured at an alternate manufacturing site located in CooperVision, Huntington Beach, California.

P790018/S037

11/9/01

Real-Time

Hall Easy-Fit™ Prosthetic Heart Valve, Models A7700 and M7700

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Hall Easy-Fit™ Prosthetic Heart Valve, Models A7700 (aortic) and M7700 (mitral), available in aortic sizes 19, 21, 23, 25, 27, and 29 mm, and in mitral sizes 23, 25, 27, 29, and 31 mm.  The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.  The Hall Easy-Fit™ Prosthetic heart Valve is a modification of the approved Medtronic Hall™ Prosthetic Heart Valve; the modification consisting of a new sewing cuff material and design, intended for supra-annular placement.  The supplement additionally requested introduction of the Hall Easy-Fit™ Prosthetic Heart Valve product line into the approved steam sterilization process for the Medtronic Hall™ Prosthetic Heart Valve.

P830045/S079

11/27/01

Real-Time

Identity Pulse Generator Model DR 5370

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Identity Pulse Generator Model DR 5370.  The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation or any combination of these symptoms.  Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.  Dual-Chamber pacing is indicated for those patients exhibiting: sick sinus syndrome; chronic, symptomatic second- and third degree AV block; recurrent Adams-Stokes syndrome; and symptomatic bilateral bundle branch clock when tachyarrhythmia and other causes have been ruled out.  Atrial pacing in indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.  Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of AV block or sinus arrest; chronic atrial fibrillation; and severe physical disability.

P860019/S177

11/8/01

Special

Maverick® Over The Wire PTCA Catheter

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for the addition of a quality control inspection step for marker band placement during the manufacturing process of the Maverick Over the Wire PTCA Catheter.

P860022/S053

11/21/01

180-Day

BOSTON® EQUALENS® (itafluorofocon A) and BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses (Wet Shipped and up to 30 day storage in Boston Advance Comfort Formula Conditioning Solution)

Bausch & Lomb

Rochester, NY

14603

Approval for wet shipping and up to 30 days storage in Boston Advance Comfort Formula Conditioning Solution.

P860057/S016

11/29/01

180-Day

Carpentier-Edwards® PERIMOUNT plus Pericardial Bioprosthesis, Model 6900P Mitral Valve

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for changes to the support assembly components of the size 25, 27, 29, and 31 mm valves.  The device, as modified, will be marketed under the trade name Carpentier-Edwards® PERIMOUNT Plus Pericardial Bioprosthesis, Model 6900P and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic mitral heart valves.

P870025/S006

11/9/01

180-Day

Corometrics Model 146 Fetal Acoustic Stimulator

GE Medical Systems Information Technologies

Wallingford, CT

06492

Approval for a manufacturing facility located at Wipro GE Medical Systems, Bangalore, India.

P870049/S031

11/9/01

Special

MicroScan® RAPID FLUOROGENIC PANELS

Dade Behring

West Sacramento, CA

95691

Approval for labeling changes to strengthen contraindications to the Rapid Gram Negative Procedural Manuals for both MIC and Breakpoint formats, which describes a limitation for performance characteristics for ESBL producing organisms and a limitation for those organisms (e.g., Enterobacter species) which express inducible beta-lactamase enzymes.

P870049/S032

11/30/01

180-Day

MicroScan® RAPID FLUOROGENIC PANELS

Dade Behring, Inc.

West Sacramento, CA

95691

Approval for labeling changes to the Rapid Gram Positive Procedural Manuals for interpretive criteria for Penicillin and Ampicillin when testing Streptococcus species other than Streptococcus pneumonia.

P870072/S015

11/30/01

180-Day

Thoratec Ventricular Assist Device

Thoratec Corporation

Pleasanton, CA

94588

Approval for the issuance of Technical Bulletin #009.

P880086/S086

11/27/01

Real-Time

Identity Pulse Generator Model XL DR 5376

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Identity Pulse Generator Model XL DR 5376.  The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation or any combination of these symptoms.  Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.  Dual-Chamber pacing is indicated for those patients exhibiting: sick sinus syndrome; chronic, symptomatic second- and third degree AV block; recurrent Adams-Stokes syndrome; and symptomatic bilateral bundle branch clock when tachyarrhythmia and other causes have been ruled out.  Atrial pacing in indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.  Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of AV block or sinus arrest; chronic atrial fibrillation; and severe physical disability.

P900061/S050

11/14/01

Special

Medtronic® GEM® ICD Model 7277 (7227Cx, 7227B, 7227D, 7227E)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the general use indication for implantable cardioverter defibrillator Models 7227Cx, 7227B, 7227D and 7227E and are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

P910023/S057

11/27/01

Real-Time

Identity Pulse Generator Model SR 5172

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Identity Pulse Generator Model SR 5172.  The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation or any combination of these symptoms.  Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.  Dual-Chamber pacing is indicated for those patients exhibiting: sick sinus syndrome; chronic, symptomatic second- and third degree AV block; recurrent Adams-Stokes syndrome; and symptomatic bilateral bundle branch clock when tachyarrhythmia and other causes have been ruled out.  Atrial pacing in indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.  Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of AV block or sinus arrest; chronic atrial fibrillation; and severe physical disability.

P920015/S024

11/2/01

Real-Time

Medtronic® Sprint™ Quattro™ Secure™ Model 6947 Lead

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® Sprint™ Quattro™ Secure™ Model 6947 Lead.  The device is indicated for single long-term use in the right ventricle.  This lead has application for patients in which arrhythmia management systems are indicated.

P930016/S014

11/6/01

Panel

VISX STAR Excimer Laser System Models S2 and S3

VISX, Inc.

Santa Clara, CA

95051

Approval for the VISX STAR S2 and S3 Excimer Laser Systems.  The devices are indicated for laser in-situ keratomileusis (LASIK) treatments:  1) in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and  2) in patients 21 years of age of older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (<= 6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.

P950009/S005

11/2/01

Real-Time

FOCALPOINT™ System

TriPath Imaging, Inc.

Redmond, WA

98052

Approval for name changes from AutoPap® Primary Screening System and AutoPap® System to FOCALPOINT™ System.  The device, as modified, will be marketed under the trade name FOCALPOINT(™System.  The FOCALPOINT™ System (AutoPap™ Primary Screening System) is indicated for:  The FOCALPOINT™ System is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slides.  The FOCALPOINT™ System identified up to 25% of successfully processed slides as requiring no further review.  The FOCALPOINT™  System also identifies at least 15% of all successfully processed slides for a second manual review.  The device is intended to be use don both conventionally-prepared and PREPSTAIN™ System cervical cytology slides.  For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as high risk.  Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.

P950029/S015

11/26/01

Real-Time

Talent and Brio Pacemakers

ELA Medical, LLC

Plymouth, MN

55441

Approval to change the silicone header currently in use with the single chamber Talent and Brio devices to Tecothane 75D polyurethane header (rigid header).

P950032/S019

11/19/01

Real-Time

Apligraf (Graftskin)

Organogenesis, Inc.

Canton, MA

02021

Approval for patient brochures for patients with chronic venous insufficiency and diabetic ulcers.  The device, as modified, will be marketed under the trade name Apligraf and is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy and for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

P950032/S020

11/7/01

180-Day

Apligraf (Graftskin)

Organogenesis, Inc.

Canton, MA

02021

Approval for a change in the Final Product Shipping Medium including the replacement of bovine insulin with full chain human recombinant insulin and the elimination of BSA, transferrin, and triiodothyronine.

P950032/S027

11/7/01

Real-Time

Apligraf (Graftskin)

Organogenesis, Inc.

Canton, MA

02021

Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 010) and a modification of the methods of keratinocyte dissociation.

P960043/S031

11/20/01

180-Day

Closer™ 6 Fr. And Closer™ S 6 Fr. SMC Systems

Perclose, Inc.

Redwood City, CA

94063

Approval for the Closer 6 Fr. Systems during interventional catheterization (expanded indications for use) requiring 7 to 8 Fr. Sheaths.  The Closer and The Closer S 6 Fr. SMC Systems are modified, as indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 8 Fr. Sheaths.  The Closer and The Closer S 6 Fr. SMC Systems reduced the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).

P940043/S033

11/28/01

135-Day

The Closer™ and The Closer™ S Cuff Tab

Perclose, Inc.

Redwood City, CA

94063

Approval for a change in the inspection method for the cuff tabs.

P960052/S003

11/19/01

180-Day

DERMABOND™ Topical Skin Adhesive

Closure Medical Corporation

Raleigh, NC

27616

Approval for the addition of a statement in the labeling that the device provides microbial barrier properties.

P970004/S017

11/1/01

180-Day

Medtronic InterStim Therapy for Urinary Control

Medtronic, Inc.

Minneapolis, MN

55421

Approval to manufacture the InterStim Models 3080 and 3886 Lead Kits and accessories at Medtronic Neurological Puerto Rico Operations, Villalba, Puerto Rico.

P970018/S003

11/2/01

Real-Time

PREPSTAIN™ System

TriPath Imaging, Inc.

Redmond, WA

98052

Approval for name changes from AutoCyte® PREP System to PREPSTAIN™ System and from CytoRich® to SUREPATH™.  The device, as modified, will be marketed under the trade name PREPSTAIN™ System and SUREPATH™.  The PREPSTAIN™ System produces slides that are intended as replacements for conventional gynecologic Pap smears.  The PREPSTAIN™ slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.

P970029/S007

11/1/01

Special

Eclipse TMR Holmium Laser System

Eclipse Surgical Technologies, Inc.

Sunnyvale, CA

94089

Approval for revisions to the SoloGrip III Instructions for Use.

P970029/S008

11/29/01

180-Day

Eclipse TMR Holmium Laser System

CardioGenesis Corporation

Foothill Ranch, CA

92610

Approval for a change in manufacturing location to Ventrex, Inc. Ventura, California.

P970031/S011

11/16/01

180-Day

Freestyle® Aortic Root Bioprosthesis, Model 995, size 29 mm

Medtronic, Inc.

Santa Ana, CA

92705

Approval for the Freestyle® Aortic Root Bioprosthesis, Model 995, size 29 mm; implantation techniques, subcoronary, full-root, and root inclusion.  The supplement requested approval of this size as an addition to the existing, approved product line of sizes 19, 21, 23, 25, and 27 mm.  The device is indicated for the replacement of malfunctioning native or prosthestic aortic valves with the option of aortic root replacement.

P970058/S011

11/13/01

180-Day

ImageChecker M1000

R2 Technology, Inc.

Los Altos, CA

94022

Approval for the use of the ImageChecker M1000 with input from the General Electric Medical Systems’ Senographe 2000 full field digital mammography system.

P970061/S012

11/29/01

180-Day

Boston Scientific/Scimed Radius™ Coronary Stent with Single-Operator Exchange (SOE) Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an additional manufacturing facility located at Boston Scientific Ireland, Ltd., Galway, Ireland and an additional sterilization facility located at Isotron, Offaly, Ireland

P980006/S004

11/20/01

Panel

PureVision™ (balafilcon A) Visibility Tinted Contact Lens

Bausch & Lomb Vision Care

Rochester, NY

14603

Approval for the Pure Vision (balafilcon A) Visibility Tinted Contact Lens.  The device is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional.  The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity.  The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +8.00D to -20.00D when prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for daily wear or extended wear up to 7 days.

P980008/S009

11/9/01

Special

LaserScan LSX Excimer Laser System

LaserSight Technologies, Inc.

Winter Park, FL

32792

Approval for a change to the quality control process that will extend the beam repeatability test from 2 to 8 hours to more accurately resemble actual field use.

P980037/S003

11/20/01

180-Day

Possis AngioJet® Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for replacement of the outflow bubble detector shutdown function on the Drive Unit 3000A with a visual alarm that is activated when bubbles are detected in the outflow line.

P980037/S004

11/20/01

180-Day

Possis AngioJet® Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for the XMI™ Catheter, a modification of the LF140 Catheter.  The device as modified, will be marketed under the trade name Possis

AngioJet® XMI™ Rheolytic™ Thrombectomy System, and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels >= 2.0 mm in diameter prior to balloon angioplasty or stent placement.

P990016/S001

11/8/01

Real-Time

McCue PLC CUBA Clinical Ultrasonic Bone Sonometry System

McCue Corporation, Inc.

Winchester, UK

S021-2AS

Approval for a software update from V4.2.0 to V4.2.1 and a new phantom (QA Coupler).

P990026/S009

11/30/01

Real-Time

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for the GlucoWatch Analyzer Software Package as an accessory to the GlucoWatch Biographer.

P990026/S010

11/30/01

Real-Time

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for extended shelf life of the QC Test Solution from 6 months to 24 months.

P990035/S004

11/30/01

180-Day

Omnisense™ 7000S Ultrasound Bone Sonometer

Sunlight Medical, Ltd.

Rehovot, Isreal

76100

Approval for a manufacturing site located at R.N.D. Networks, Ltd., Jerusalem, Isreal.

P990037/S001

11/2/01

180-Day

Diagnostic DUETT

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for the change in diluent and procoagulant components.  The device, as modified, will be marketed under the trade name Diagnostic DUETT and is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5F-9F introducer sheath with an overall length not exceeding 15.2 cm.

P990050/S003

11/28/01

Real-Time

WavSTAT™ Optical Biopsy System with Model II Console

SpectraScience, Inc.

Minneapolis, MN

55447

Approval for a new console to be used with the OBS.  This new console consists of a reconfiguration of the original console and incorporates several features intended to improve usability of the device.

P990064/S005

11/21/01

180-Day

Medtronic Mosaic® Porcine Bioprostheses, Model 310 (Mitral)

Medtronic Heart Valves

Santa Ana, CA

92705

Approval for The Mosaic® Porcine Bioprosthesis, Model 310 Mitral, 33 mm.

P990074/S004

11/7/01

180-Day

McGhan RTV Saline-Filled Breast Implants

McGhan Medical Corporation

Santa Barbara, CA

93111

Approval for revised patient labeling that incorporates the results of the focus group study.

P000016/S001

11/9/01

180-Day

Corometrics Model 120 Series Maternal/Fetal Monitor with Integrated Fetal Pulse Oximetry

GE Medical Systems Information Technologies

Wallingford, CT

06492

Approval for manufacturing facility located at Wipro GE Medical Systems, Bangalore, India.

P000020/S005

11/21/01

Real-Time

Bard Stinger™ and Stinger S™ Ablation Catheter and TempLink™ Extension Cable

C.R. Bard, Inc.

Lowell, MA

01851

Approval for use of the Bard Stinger and Stinger S Ablation Catheter and TempLink Extension Cable for use with the Cordis Stockert 70W RF Generator.  The device, as modified, will be marketed under the same trade name and is indicated for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.

P990053/S003

11/9/01

OxyFirst™ Fetal Sensor, FS14-Series

TycoHealthcare/ Nellcor Puritan Bennett

Pleasanton, CA

94588

Change in the sterilization process by eliminating the post sterilization visual inspection for the OxyFirst™ Fetal Sensor FS14-Series.  Also a change in the site of final product distribution from the present facility in Carlsbad, California to a Tyco distribution facility in Atlanta, Georgia.