P020031

9/23/03

Microsulis Microwave Endometrial Ablation (MEA) System

Microsulis Medical Ltd.

Denmead Hampshire, UK

PO7 6XP

Approval for the Microsulis Microwave Endometrial Ablation (MEA) System.  The device is indicated for ablation of the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

P020035

9/30/03

X-PRESS™ 6 French Vascular Closure System

X-SITE Medical, L.L.C.

Blue Bell, PA

19422

Approval for the X-PRESS 6 French Vascular Closure System.  The device is 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 sheaths less than or equal to 6 French in size.  The device is intended to reduce the time to hemostasis, time to ambulation (100 feet), and time to dischargeability in patients who have undergone diagnostic or interventional cardiac catheterization procedures without complicating clinical conditions, including those patients receiving Glycoprotein IIb/IIIa inhibitors.

P780007/S043

9/12/03

180-Day

Biomedics 38 (polymacon) UV Blocking Contact Lenses

Ocular Sciences, Inc.

Albuquerque, NM

87101

Approval for a manufacturing site located at Ocular Sciences, Albuquerque, New Mexico.

P830079/S014

9/26/03

Real-Time

INSTAT® Absorbable Collagen Hemostat

Johnson & Johnson Wound Management, Ethicon, Inc.

Somerville, NJ

08876

Approval for removal of the neurological exclusion from the “indications for use” statement.  The device, as modified, will be marketed under the trade name INSTAT® Absorbable Collagen Hemostat and is indicated for use “…in surgical procedures (other than in ophthalmological surgery) as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures in ineffective or impractical.  INSTAT Hemostat can be cut to size for use in endoscopic procedures.”

P840001/S070

9/17/03

Real-Time

Itrel 3, Synergy and Synergy Versitrel

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Resume II Model 3587A, the Resume TL Model 3986A, the On-Point Model 3987A and the SymMix Model 3982A leads.

P860004/S056

9/12/03

180-Day

Medtronic® SynchroMed® II Programmable Drug Infusion System

Medtronic Neurological, Medtronic Inc.

Minneapolis, MN

55432

Approval for the Medtronic® SynchroMed® II Programmable Drug Infusion System which includes Model 8637 SynchroMed II Programmable Pump, SynchroMed II Application Softwaare on the Model 8870 Application Card, Model 8551 Refill Kit, Model 8540 Catheter Access Port Kit, and Model 8590-1 Pouch Kit.

P890003/S071

9/17/03

Real-Time

Medtronic Model 2490D/E CareLink Monitors and Model 2491 DDMA Software for InSync ICD, Model 7272 and InSync Marquis, Model 7277

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490D/E CareLink Monitors and Model 2491 DDMA Software to allow their use with the InSync ICD Model 7272 & InSync Marquis Model 7277.  The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. 

P900023/S038

9/24/03

180-Day

ABIOMED® AB5000™ Circulatory Support System

ABIOMED, Inc.

Danvers, MA

01923

Approval for the AB5000 blood pump, used only with the AB5000 Console.  The device, as modified, will be marketed under the trade name ABIOMED® AB5000™ Circulatory Support System and is indicated for use in patients suffering from reversible ventricular dysfunction.  These are patients who have undergone successful cardiac surgery and subsequently develop low cardiac output, or patients who suffer from acute cardiac disorders leading to hemodynamic instability.  The intent of AB5000 System therapy is to provide circulatory support, restore normal hemodynamics, reduce ventricular work, and allow the heart time to recover adequate mechanical function. The AB5000 Ventricle is external to the patient and is intended for short-term use. 

P930014/S012

9/2/03

Special

ACRYSOF® NATURAL Single Piece Intraocular Lens

Alcon Research Ltd.

Fort Worth, TX

76134

Approval to modify the package insert to create a new warning by moving and strengthening existing text within the approved insert to read as follows: “The clinical study of the ACRYSOF® NATURAL Single-Piece Lens (referenced in Tables 2 through 5) was conducted with the lens intended for implantation in the capsular bag only.  There is no clinical data to demonstrate its safety and effectiveness for placement in the ciliary sulcus.”

P940015/S006

9/26/03

Real-Time

Synvisc® Hylan G-F 20

Genzyme Corporation

Cambridge, MA

02139

Approval for labeling changes including removal of a precaution regarding repeat courses of injection, and adding information about adverse events.

P940015/S010

9/12/03

Special

Synvisc® Hylan G-F 20)

Genzyme Corporation

Cambridge, MA

02139

Approval for changes to the patient package insert for Synvisc® that are intended to strengthen the information for patients by increasing the type size, decreasing the reading level, more fully describing the U.S. clinical trial, describing the signs of an allergic reaction, and by making other revisions to the insert.

P950019/S015

9/4/03

Special

Ray Threaded Fusion Cage (TFC™)

Stryker Howmedica Osteonics

Allendale, NJ

07401

Approval for labeling changes and changes in part numbers.

P950021/S006

9/2/03

Real-Time

Bayer ADVIA IMS® PSA Assay

Bayer HealthCare, LLC

Tarrytown, NY

10591

Approval of the Immuno 1™ Prostate Specific Antigen (PSA) on the ADVIA Integrated Modular System (IMS).  The device, as modified, will be marketed under the trade name ADVIA IMS® Prostate Specific Antigen (PSA) and is indicated for:  The ADVIA IMS® Prostate Specific Antigen (PSA) method is for in vitro diagnostic use to quantitatively measure prostate specific antigen (PSA) in human serum.  This assay is indicated for the measurement of the serum PSA in conjunction with Digital Rectal Exam (DRE) as an aid in the detection of prostate cancer in men aged 50 year and older.  This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.  This diagnostic method is not intended for use on any other system.

P950034/S026

9/29/03

Real-Time

Seprafilm® Adhesion Barrier

Genzyme Corporation

Cambridge, MA

02142

Approval for the Seprafilm labeling.

P960043/S047

9/2/03

Real-Time

Prostar XL 8 and 10 French, Closer, Closer S, Perclose AT, and Perclose AT Monofilament 6 French Suture Mediated Closer (SMC) Devices

Perclose, Inc.

An Abbott Laboratories Company

Redwood City, CA

94063

Approval to add wording in the Precautions section in the labeling, informing the user that reaccess/

repuncture of the femoral artery with the above listed devices is not restricted for patients who have previously received these devices in earlier arteriotomy repairs.

P970003/S046

9/30/03

180-Day

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Houston, TX

77058

Approval for an alternative sterilization process (hydrogen peroxide gas plasma using  the STERRAD® 200 GMP Sterilizer) for the Model 401 Tunneler and approval of a protocol for B1 incubation reduction and shelf life study, as well as a new sterilization facility (Cyberonics, Inc., Houston, Texas).

P970015/S022

9/10/03

180-Day

LT-Cage™ PEEK Lumber Tapered Fusion Device

Sofamor Danek USA

Memphis, TN

38132

Approval for the LT-Cage™ PEEK Lumber Tapered Fusion Device, which is manufactured from Polyetheretherke-tone, with the trade name of PEEK-Optima® LT1.  The device, as modified, will be marketed under the trade name LT-Cage™ PEEK Lumbar Tapered Fusion Device and is indicated for spinal fusion procedures in skeletally mature patients with degernerative disc disease (DDD) at one level from L2-S1.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.  These DDD patients also have up to Grade I spondylolisthesis or retrolisthesis at the involved level.  LT-Cage™ PEEK implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach.  Patients receiving the LT-Cage™ PEEK Lumbar Tapered Fusion Device should have at least six months of non-operative treatment prior treatment with the LT-Cage™ PEEK device.

P970015/S025

9/17/03

180-Day

INTER FIX™ Threaded Fusion Device

Sofamor Danek USA

Memphis, TN

38132

Approval for a modification to the approved post-approval study.

P970043/S014

9/12/03

Real-Time

LADARVision® 4000 Excimer Laser System

Alcon Laboratories, Inc.

Orlando, FL

32826

Approval for the CustomCornea® Surgery Planning Software to be used with the LADARVision® 4000 Excimer Laser System which will allow treatment planning by the practitioner prior to the actual date of surgery.  The device, as modified, will be marketed under the trade name LADARVision® 4000 Excimer Laser System and is indicated for the reduction or elimination of myopia up to -7.00 D with less than -0.50 D of astigmatism at the spectacle plane.

P970051/S026

9/25/03

Real-Time

Nucleus 24 Cochlear Implant System with Contour Softip Electrode

Cochlear Americas

Englewood, CO

80112

Approval for decreasing the radius of the magnet opening in the silicone.

P970058/S016

9/10/03

180-Day

ImageChecker® M1000

R2 Technology, Inc.

Sunnyvale, CA

94086

Approval for a new software release (V5.0) that:  1) provides the user with a choice of two operating points (one with higher sensitivity and increased false marks and the other with lower false marks with decreased sensitivity, chosen at the time of device installation) for use with film/screen images only;  2) when packaged with V3.1A software in a single Image Checker housing, allows the processing of both analog and GE FFDM images;  3) allows CAD processing of GE FFDM DICOM images formatted for Presentation; and  4) reduces the number of oversized malignant calcification  clusters missed by earlier algorithms.

P980003/S007

9/2/03

180-Day

Chilli II® Cooled Ablation Catheter

Boston Scientific Corporation

San Jose, CA

95134

Approval for the Chilli II® Cooled Ablation Catheter.  The device is indicated for cardiac electrophysiological mapping; delivery diagnostic pacing stimuli; and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.

P980046/S006

9/8/03

180-Day

Home Access Hepatitis C Check Test

Home Access Health Corporation

Hoffman Estates, IL

60195

Approval for a manufacturing site located at Fitzco, Inc., Spring Park, Minnesota.

P990001/S014

9/16/03

180-Day

Vitatron C60DR Model C60A1, Vitatron C20SR Model C20A, C series Software Model VSF03 version 1.1 and VSF04 Version 1.1 SR 1, Vitatron Desktop Model VSH03 version 1.1 and VSH04 version 1.1 SR 1, Vitatron CD-ROM VSE03 version 1.1 and VSE04 version 1.1 SR 1

Medtronic, Inc.

Minneapolis, MN

55432

Approval for modifications to rate response features, addition of Telemetry B, and other diagnostic enhancements.  The device, as modified, will be marketed under the trade name Medtronic/Vitatron DA+ C-Series Implantable Generators and is indicated as follows:   1)   Dual chamber pacing is indicated if AV synchrony needs to be restored in order to optimize cardiac output. For example, patients with symptomatic second or third degree AV block.  2) Dual chamber rate responsive pacing modes are of specific benefit to patients with chronotropic incompetence of the sinus node.  3) Rate responsive modes can help patients who have a requirement for an

increase in pacing rate in response to physical activity.

4) Single chamber ventricular pacing can help patients with permanent atrial

tachyarrhythmias, including atrial fibrillation and flutter.  5) Single chamber atrial pacing can help patients with symptomatic bradyarrhythmias

and normal AV conduction.

P990014/S004

9/16/03

Real-Time

Hydroview® Composite Hydrogel Foldable Ultraviolet-Absorbing Posterior Chamber Intraocular Lens

Bausch & Lomb

San Dimas, CA

91773

Approval for a new trade name for the HP60M Hydrogel IOL.  The device, as modified, will be marketed under the trade name “Meridian” and is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed by extracapsular extraction methods.  The lens is designed for implantation in the capsular bag following extracapsular cataract extraction.

P990055/S007

9/2/03

Real-Time

Bayer Advia IMS cPSA assay

Bayer HealthCare, LLC

Tarrytown, NY

10591

Approval for the addition of the cPSA assay to the Bayer Advia IMS system.  The device, as modified, will be marketed under the trade name Bayer Advia IMS cPSA assay and is indicated as an aid in the detection of prostate cancer in men aged 50 years or older in conjunction with digital rectal exam.

P990069/S001

9/29/03

180-Day

ALERT® System (Companion ™ II with Software Version 1.20)

EPMed Systems, Inc.

West Berlin, NJ

08091

Approval for the Alert System, Companion II.  The device, as modified, is indicated for use in patients who are candidates for transvenous electrical cardioversion for the treatment of atrial fibrillation.

P000013/S002

9/12/03

Real-Time

Osteonics ABC/Trident Systems

Howmedica Osteonics Corporation

Allendale, NJ

07401

Approval for revisions to the Trident Acetabular System package insert and patient labeling.  These changes include editing text for conciseness and clarity, reorganizing elements to more clearly convey intent, and presenting data in a manner that is less confusing and more meaningful to patients and surgeons.

P000052/S020

9/3/03

Special

GALILEO® Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for labeling changes as a short term corrective action to a complaint investigation.

P000058/S006

9/17/03

180-day

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

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for a retrieved implant protocol used to obtain data to comply with one of the conditions of approval.

P010025/S002

9/24/03

Real-Time

Selenia™ Full Field Digital Mammographic System

Lorad-A Hologic Company

Danbury, CT

06810

Approval for the following changes in the Selenia™ QC Manual:  1) Change the minimum scores for the ACR Phantom test to 5 fibers, 4 specs, and 4 masses form 4 fibers, 4 specs, and 3 masses.  2) Change the Signal-to-Noise test result minimum from 40 to 35.  The 40 value was based on the use of the BR-12 phantom, whereas the standard phantom is the ACT with a minimum value of 35.  3) Add a specification of 28 k Vp and 65 mAs for performance of QC testing.

P010030/S004

9/2/03

Real-Time

LifeVest™ (WCD® 3000) Wearable Defibrillator

LIFECOR®, Inc.

Pittsburgh, PA

15238

Approval for minor software, hardware, and labeling changes.  The device, as modified, will be marketed under the trade name LifeVest™ (WCD® 3000) Wearable Defibrillator and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

P010031/S007

9/17/03

Real-Time

Medtronic Model 2490D/E CareLink Monitors and Model 2491 DDMA Software for InSync ICD, Model 7272 and InSync Marquis, Model 7277

Medtronic, Inc.

Minneapolis, MN 55432

Approval for the Model 2490D/E CareLink Monitors and Model 2491 DDMA Software to allow their use with the InSync ICD Model 7272 & InSync Marquis Model 7277.  The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. 

P790018/S044

9/23/03

Medtronic Hall™ Prosthetic Heart Valves (Models

A7700 and M7700)

Medtronic Cardiac Surgery

Minneapolis, MN

55432

Elimination of the production pulse duplication test from the manufacturing process.

P860019/S197

9/3/03

Maverick Monorail PTCA Catheter, Maverick 2 Monorail PTCA Catheters, Quantum Maverick Monorail PTCA Catheter, Express/

Express2 Coronary Stent System

Boston Scientific Ireland

Maple Grove, MN

55311

Change in the sterilization parameters.

P860019/S198

9/3/03

NC Monorail PTC Catheter, Quantum Monorail PTCA Catheter, Maxxum PTCA Catheter, Viva PTCA Catheter and Adante PTCA Catheter

Boston Scientific Ireland

Maple Grove, MN

55311

Change in the sterilization parameters

P900060/S027

9/23/03

Prosthetic Heart Valves

CarboMedics, Inc.

Austin, TX

78752

Additional supplier of bovine bones.

P930031/S017

9/11/03

Wallstent® TIPS Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Change in sterilization parameters.

P940019/S015

9/11/03

Wallstent® Iliac Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Change in sterilization parameters.

P950032/S035

9/15/03

Apligraf™

Organogenesis, Inc.

Canton, MA

02021

Substitution of the current manufacturer (Eli Lilly and Co., distributed by Gibco) to a different manufacturer (Novo Nordisk S/A, distributed by Gibco).  Also, substituting non-human components with human components.

P980033/S007

9/11/03

Wallstent® Venous Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Change in sterilization parameters.

P990046/S008

9/16/03

ATS Medical Heart Valve

ATS Medical, Inc.

Minneapolis, MN

55447

Addition of a source supplier.

P990046/S009

9/23/03

ATS AVG (Aortic Valved Graft)

ATS Medical, Inc.

Minneapolis, MN

55447

Change in the sterilization validation protocol for the ATS AVG (Aortic Valved Graft)

P020009/S010
9/3/03

Maverick Monorail PTCA Catheter, Maverick 2 Monorail PTCA Catheters, Quantum Maverick Monorail PTCA Catheter and Express/

Express2 Coronary Stent System

Boston Scientific Ireland

Maple Grove, MN

55311

Change in the sterilization parameters.