D980003

11/26/03

Keramos™ Ceramic/Ceramic Total Hip System

Encore Medical, L.P.

Austin, TX

78758

Approval for the Keramos™ Ceramic/Ceramic Total Hip System.  The device is indicated for use in patients requiring primary total hip arthroplasty for the treatment of inflammatory tissue disorders and non-inflammatory degenerative joint disease, including osteoarthritis, post-traumatic arthritis or secondary arthritis, and avascular necrosis.

P030002

11/14/03

crystalens™ Model AT-45 Accommodating Posterior Chamber Intraocular Lens (IOL)

Eyeonics, Inc.

Aliso Viejo, CA

92656

Approval for the crystalens Model AT-45 Accommodating Posterior Chamber IOL.  The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed and is intended to provide near, intermediate and distance vision without spectacles.  The Crystalens IOL provides approximately one diopter of monocular accommodation.

N12159/S019

11/17/03

180-Day

Surgicel/

Surgicel Nu-Knit/ Surgicel Fibrillar Absorbable Hemostat

Johnson & Johnson Wound Management

Somerville, NJ

08876

Approval for a sterilization site located at Steris Isomedix Services, Vega Alta, Puerto Rico.

P790018/S045

11/28/03

180-Day

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

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Biotest Laboratories, Inc. Minneapolis, Minnesota.

P830055/S086

11/18/03

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for a line extension to the LCS Complete femoral components.  That is, the addition of LCS Complete Modular Femoral Components (sizes small – large+).  The LCS Complete Modular Femoral Components combine features of the previously approved LCS Complete primary and revision femoral components.

P830055/S087

11/18/03

Real-Time

 LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

 Approval for a line extension to the P.F.C. Sigma components.  That is, the addition of P.F.C. Sigma RPF Femoral Components and Tibial Bearings (sizes 1, 1.5, 2, 2.5, 3, 4, 5, and 6).  The P.F.C. Sigma RPF components allow for a higher than normal degree of flexion after total knee arthroplasty (~155 º).

P830060/S052

11/21/03

Special

Bi-directional Torque Wrench Model 6942

Guidant Corporation

St. Paul, MN

55112

Approval for a labeling change to include text versions and more descriptive application diagrams for using the bi-directional Torque Wrench (Model 6942) and Hex Wrench (Model 6501).  The new labeling also specified that the device is sterilized, non-pyrogenic and single use only.

P840001/S071

11/17/03

180-Day

Model 7425 Itrel II, Model 7427 Synergy and Model 7427V Synergy Versitrel Dual Channel Implantable (DCI) Pulse Generator

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P860004/S057

11/18/03

Real-Time

Medtronic Model 8749 Intrathecal Catheter

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the changes to the Model 8731 intrathecal catheter to include  1) a change to the length of proximal and distal segments of the catheter;  2) a change to the tubing connector,  3) revisions to Model 8596 and Model 8749 revision kits,  4) revisions to the catheter tubing specifications; and 5) addition of a crimp sleeve to the guide wire.

P860022/S055

11/25/03

Real-Time

Boston® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lens for Extended Wear

Bausch & Lomb

Rochester, NY

14609

Approval for combining the daily wear and extended wear labeling of the device to bring the extended wear labeling into alignment with the daily wear labeling.

P860047/S015

11/25/03

135-Day

Ocucoat® (2% Hydroxypropyl-methylcellulose Solution)

Bausch & Lomb

San Dimas, CA

91773

Approval for a change in the frequency of the EO residual testing for the Ocucoat.

P860057/S018

11/14/03

180-Day

Carpentier-Edwards® Perimount Magna™ Pericardial Bioprosthesis, Model 3000 Aortic

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for design and manufacturing modifications to the sewing ring/support assembly components of the Model 2800 Aortic valve, sizes 19, 21, 23, 25, 27, and 29 mm.  The device, as modified, will be marketed under the trade name Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis, Model 3000 Aortic and is indicated for the replacement of malfunctioning native or prosthetic aortic heart valves using the supra-annular or intra-annular implantation technique.

P870072/S023

11/20/03

Real-Time

Thoratec® Paracorporeal Ventricular Assist Device (PVAD) System and TLC-II Portable VAD Driver

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval for the use of the VAD system in the home environment and for the addition of two accessories for the Thoratec VAD system: the Mobile Computer and the Car Power Adapter.  The device, as modified, will be marketed under the trade name Thoratec® Paracorporeal Ventricular Assist Device System and TLC-II Portable VAD Driver.  The PVAD is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support.  It is also indicated for post cardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass.  The TLC-II portable pneumatic driver is intended for use both inside and outside the hospital or for transportation of VAD patients via ground ambulance.

P870072/S026

11/26/03

Real-Time

Thoratec® Paracorporeal Ventricular Assist Device (PVAD) System and TLC-II Portable VAD Driver

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval to expand the indications for use to include transport of patients in fixed wing aircraft and in helicopters.  This device, as modified, will be marketed under the trade name Thoratec® Paracorporeal Ventricular Assist Device System and TLC-II Portable VAD Driver.  The PVAD is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support.  It is also indicated for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass.  When used with the TLC-II portable pneumatic driver, the PVAD is intended for use for transportation of VAD patients via ground ambulance, fixed wing aircraft or helicopter.  In addition, the TLC-II portable pneumatic driver can be used to allow suitably-qualified patients to take off-site excursions within a two-hour travel radius of the hospital in the company of a trained caregiver.

P890003/S072

11/17/03

180-Day

IPGs: Thera/Prodigy and Viatron Legacy II DR

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P890064/S013

11/7/03

Real-Time

Hybrid Capture® 2 High-Risk HPV DNA Test™ and Hybrid Capture® HPV DNA Test™

Digene Corporation

Gaithersburg, MD

20878

Approval for:  1) Modification of hybridization procedural steps and sequence, an additional 10 minute incubation period, and changes to the equivocal result zone.

P910023/S071

11/6/03

Real-Time

Housecall Plus™ Transtelephonic Monitoring System with Model 3180-T Transmitter (software version 1.10) and Model 3180-R Receiver (software version 1.0)

St. Jude Medical

Sunnyvale, CA

94086

Approval for modifications to the Housecall 2.0 System.  The device, as modified, will be marketed under the trade name Housecall Plus™ Transtelephonic Monitoring System and is indicated as follows:   The Housecall Plus™ System is indicated for use in performing remote follow-up monitoring on patients having the following St. Jude Medical cardioverter/ defribrillators:  Atlas® DR model V-240, Atlas® VR model V-199, Epic™+ DR model V-236, Epic™+ VR model V-196, Epic™ DR model V-235 and Epic™ VR model V-197.

P910073/S041

11/4/03

180-Day

ENDOTAK® RELIANCE® G Endocardial Defibrillation Lead, Models 0164, 0165, 0166, 0167, 0174, 0175, 0176, 0177 and ENDOTAK® RELIANCE® SG Endocardial Defibrillation Lead, Models 0160, 0161, 0162, 0163

Guidant Corporation

St. Paul, MN

55112

Approval to modify the active and passive fixation ENDOTAK® family of defibrillation leads and to package the leads with a transvalvular insertion tool for use with a hemostatic introducer.  The leads, as modified, will be marketed under the trade name ENDOTAK® RELIANCE® G Endocardial Defibrillation Lead, Models 0164, 0165, 0166, 0167, 0174, 0175, 0176, 0177 and ENDOTAK® RELIANCE® SG Endocardial Defibrillation Lead, Models 0160, 0161, 0162, 0163.

P920023/S017

11/14/03

Special

Urolume® Endourethral Prosthesis for Bulbar Urethral Strictures, Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy, and Detrusor External Sphincter Dyssynergia

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for changes to the labeling regarding the deployment of the device and withdrawal of the delivery instrument.

P930035/S011

11/21/03

Special

Hex Wrench Model 6501

Guidant Corporation

St. Paul, MN

55112

Approval for a labeling change to include text versions and more descriptive application diagrams for using the bi-directional Torque Wrench (Model 6942) and Hex Wrench (Model 6501).  The new labeling also specified that the device is sterilized, non-pyrogenic and single use only.

P960009/S028

11/17/03

180-Day

Model 7426 Soletra and Model 7428 Kinetra Implantable Neurostimulator

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P960016/S012

11/21/03

Real-Time

Livewire TC™ Cardiac Ablation System

St. Jude Medical

Daig Division, Inc.

Minnetonka, MN

55345

Approval for the new Livewire TC™ Catheter Extension Cable-Stockert, a new cable with thermocouple sensing only for use with the Stockert 70 Radiofrequency Cardiac Ablation Generator.

P960043/S046

11/25/03

180-Day

Closer™ XL Suture Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for various dimensional changes which result in a larger version of the original device.  The device, as modified, will be marketed under the trade name Closer™ XL Suture Mediated Closure (SMC) System and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access sites of patients who have undergone diagnostic and interventional catheterization procedures using 8 Fr sheaths.

P960043/S049

11/25/03

Special

Perclose AT 6 French Suture Mediated Closer (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for changes to the instructions for use.  These changes strengthen the procedural instructions for using the device and add a precaution to not use excessive force or torque to advance the device, stating that such actions may result in: “…significant arterial damage and/or breakage of the device, which may necessitate surgical removal of the device and arterial repair.”  In addition to these labeling changes, the physician training protocol has been revised to further address this concern.

D970003/S024

11/4/03

180-Day

INSIGNIA® I Ultra Implantable Pacemaker System Models 1290, 1291 and 1190 with Model 2892 Programmer software, version 1.23

Guidant Corporation

St. Paul, MN

55112

Approval to modify the INSIGNIA® I Plus Implantable Pacemaker System.  The device, as modified, will be marketed under the trade name INSIGNIA® I Ultra and is indicated for:  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 without associated AV conduction disorders  4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachycardia; and  5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.  Adaptive-rate pacing is indicated ror patients who may benefit from increased pacing rates concurrent with increases in MV and/or level of physical activity.  The INSIGNIA® I Ultra 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/S049

11/20/03

Special

VNS Therapy™ System

Cyberonics, Inc.

Houston, TX

77058

Approval for changes to simplify the language in the Patient’s Manual.

P970004/S026

11/17/03

180-Day

Interstim Model 3023 and Transcend Model 3726 Implantable Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P970012/S015

11/17/03

180-Day

IPGs: Kappa 400

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P970043/S017

11/21/03

Special

Alcon LADARVision® 4000 Excimer Laser System

Alcon Laboratories, Inc.

Fort Worth, TX

76134

Approval for labeling changes to the Surgery Planning Software.

P970051/S025

11/7/03

180-Day

Nucleus® 24 Cochlear Implant System with Contour Advance™

Cochlear Americas

Englewood, CO

80112

Approval of a marketing name change from Nucleus® 24 Cochlear Implant System with Contour Softip™ Electrode to Nucleus® 24 Contour Advance™.

P970058/S017

11/25/03

180-Day

ImageChecker LX and ImageChecker DX (software version 6.0)

R2 Technology, Inc.

Sunnyvale, CA

94087

Approval for the addition of a new digitizer, the Vidar Diagnostic Pro film digitizer and new CAD software, version 6.0.  The device, as modified, will be marketed under the trade name ImageChecker LX and ImageChecker DX depending upon options chosen.  The indications are:  The ImageChecker LX/DX is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed.  Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second view.

P970058/S018

11/26/03

Real-Time

ImageChecker D, DM, and OEM-D (Software version 5.1)

R2 Technology, Inc.

Sunnyvale, CA 94087

Approval for the use of the ImageChecker® system with the Fischer Imaging’s SenoScan® Full Field Digital Mammography System.  The device, as modified, will be marketed under the trade names ImageChecker D (digital mammography only), ImageChecker DM (digital and analog mammography), and ImageChecker OEM-D (digital mammography only, sold by FFDM vendor).  The modified device would be supported by software version 5.1.  The indications for use are:  The ImageChecker D/DM.OEM-D is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed.  Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

P980016/S036

11/17/03

180-Day

ICDs: Marquis DR and Marquis VR

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P980023/S012

11/18/03

180-Day

Kentrox RV-S and Kentrox SL-S ICD Leads

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Kentrox RV-S and Kentrox SL-S leads.

P980031/S006

11/5/03

180-Day

INTACS Prescription Inserts

Addition Technology

Sunnyvale, CA

94089

Approval for a manufacturing site in Sunnyvale, California.

P980035/S031

11/17/03

180-Day

IPGs: Kappa 700/900, Sigma, Medtronic 350 Series, Viatron and AT 500

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P980050/S014

11/17/03

180-Day

Jewel AF 7250

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P990023/S002

11/14/03

Special

Cellugel Ophthalmic Viscosurgical Device

Alcon Laboratories

Fort Worth, TX

76134

Approval for adding the precaution, “use only if the container is undamaged”.

P990026/S018

11/20/03

180-Day

GlucoWatch G2 Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for modifications to the signal processing routine and data point screening parameters of the Biographer to reduce the number of skipped readings, modifications to the DOWN alert of the Biographer to increase the specificity of the alarm feature and an Autosensor formulation change to improve the Biographer calibration.

P990035/S005

11/17/03

180-Day

Omnisence 7000S Ultrasound Bone Sonometer

Sunlight Medical Ltd.

Rehovot, Israel

76100

Approval for a manufacturing site located at Zicon Ltd., Petah-Tikva, Israel.

P990045/S005

11/26/03

Real-Time

DiaSorin ETI-AB-COREK PLUS Assay

Diasorin, Inc.

Stillwater, MN

55082

Approval for extension of the ETI-AB-COREK PLUS Assay expiration dating from 7 months and a minor labeling change in the analytical sensitivity section of the package insert to correct a calculation error.

P000009/S009

11/13/03

180-Day

Lexos VR, Lexos VR-T, Lexos DR Lexos DR-T, Belos DR, Belos DR-T, Belos VR, Belos VR-T, Cardiac Airbag-T and microPhylax Implantable Cardioverter Defibrillators and Programmer Software (A-K00.1.U/4)

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Lexos family of implantable cardioverter defibrillators (ICDs) and software modifications to the Belos family of ICDs, the Cardiac Airbag-T and the microPhylax ICD.  The new device will be marketed under the trade name Lexos VR, Lexos VR-T, Lexos DR, Lexos DR-T Implantable Cardioverter Defibrillators and Programmer Software (A-K00.1.U/4).

P000011/S010

11/5/03

Special

Phosphorylcholine (PC) coated BiodivYsio™ SV and OC stent premounted on an Over-the-Wire (OTW) delivery system (BiodivYsio™ SV and OC OTW)

Abbott vascular Devices

Redwood City, CA

94063

Approval to update the compliance charts to enhance the accuracy of the labeling for the PC coated BiodivYsio™ SV and OC OTW stent delivery systems.

P000013/S003

11/13/03

180-Day

Osteonics ABC/Trident Systems

Howmedica Osteonics Corporation

Allendale, NJ

07401

Approval of the post-approval study protocol for the device.

P000028/S004

11/13/03

180-Day

AFFINITY™ Anterior Cervical Cage System

Medtronic Sofamor Danek

Memphis, TN

38012

Approval for a revised explant protocol.

P010002/S004

11/12/03

Real-Time

Indermil® Tissue Adhesive

U.S. Surgical, a division of Tyco Healthcare Group, LP

Norwalk, CT

06856

Approval for the addition of a cannula to the applicator and a microbial barrier claim to the labeling.  The device, as modified, will be marketed under the trade name Indermil® Tissue Adhesive and is indicated for the closure of topical skin incisions including laparoscopic skin incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges.  In vitro studies have also shown that Indermil may act as a barrier to microbial penetration when the adhesive film remains unbroken.  Indermil tissue adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

P010015/S011

11/17/03

180-Day

IPGs: InSync and InSync III

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P010018/S003

11/6/03

180-Day

ViewPoint™ CK^sm System

Refractec, Inc.

Irvine, CA

92618

Approval for updating the labeling with the 24 month clinical study results.

P010031/S009

11/17/03

180-Day

IPGs: InSync Marquis and InSync II Marquis

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) MedRel, Juncos, Puerto Rico.

P790019/S017

11/6/03

IMx® HAVAB®-M (List Number 2263)

Abbott Laboratories

Abbott Park, IL

60064

Discontinue the use of Reference Panel 4 and eliminate all associated validity and acceptance criteria from both the incoming alkaline phosphatase and the IMx HAVAB-M conjugate concentrate testing.

P920047/S020

11/25/03

EPT-1000 Cardiac Ablation System

Boston Scientific Corporation

Elimination of a chemical from the ring cleaning procedure and the implementation of the new automated curing fixture.

P000018/S039

11/18/03

Novoste™

Beta-Cath™ System

Novoste Corp.

Norcross, GA

30093

New supplier for the Pressure Indicator Printed Circuit Board Assembly (PIB).

P020006/S001

11/26/03

Enteryx® Procedure Kit

Boston Scientific

Natick, MA

01760

Modify the method of capping the vials of Enteryx® and DMSO and modify the overlaying process.

P020024/S001

11/13/03

AMPLATZER® Duct Occluder and AMPLATZER® Delivery and Exchange System

AGA Medical Corporation

Golden Valley, MN

55427

Alternate manufacturing vendor for the AMPLATZER 180 Delivery and Exchange System.