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PMA Final Decisions Rendered for March 2005

P040017

3/7/05

ADVIA Centaur® HAV Total Assay, ADVIA Centaur® HAV Total Quality Control Materials

Bayer Healthcare, LLC

Tarrytown , NY

10591

Approval for the ADVIA Centaur® HAV Total Assay and Quality Control Materials. HAV Total Assay Indication for Use: The ADVIA Centaur HAV Total Assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV ) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur System. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. HAV Total Quality Control Materials Indication for Use: For monitoring the performance of the HAV Total Assay on ADVIA Centaur® Systems. The performance of the HAV Total Quality Control Material has not been established with any other anti-HAV Total Assay.

P040020

3/21/05

AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3

Alcon Research Ltd.

Fort Worth , TX

76134

Approval for the AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lenses (IOLs), Models MA60D3 and SA60D3. This device is indicated for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

P040024

3/25/05

Restylane™ Injectable Gel

Medicis Aesthetics Holdings, Inc.

Scottsdale , AZ

85258

Approval for the Restylane™ Injectable Gel. The device is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

P040043

3/23/05

GORE TAG Thoracic Endoprosthesis

W.L. Gore and Associates

Flagstaff , AZ

86001

Approval for the TAG Thoracic Endoprosthesis and delivery catheter. The device is intended for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy including: 1) Adequate iliac/femoral access. 2) Aortic inner diameter in the range of 23-37 mm. 3) ≥2 cm non-aneurysmal aorta proximal and distal to the aneurysm.

P790017/S082

3/4/05

Real-Time

NC Stormer MX 2 and OTW Balloon Dilatation Catheters

Medtronic Vascular, Inc.

Santa Rosea , CA

95403

Approval for addition of the NC Stormer MX 2 catheter with two additional lengths (as a modified version of the approved NC Stormer MX catheter) and the addition of two additional lengths for the NC Stormer OTW catheter.

P810032/S051

3/4/05

135-Day

PMMA VS-100 MP PC IOL

Alcon Research LTD.

Fort Worth , TX

76134

Approval for the use of an additional supplier of polymethylmethacrylate (PMMA) for the PMMA IOLs.

P840060/S029

3/4/05

135-Day

PMMA Single-Piece IOL

Alcon Research LTD.

Fort Worth , TX

76134

Approval for the use of an additional supplier of polymethylmethacrylate (PMMA) for the PMMA IOLs.

P840064/S026

3/23/05

180-Day

DisCoVisc™ Ophthalmic Viscosurgical Device

Alcon Research Ltd.

Fort Worth , TX

76134

Approval for the DisCoVisc™ Ophthalmic Viscosurgical Device.

P860004/S064

3/24/05

Real-Time

SynchroMed Infusion System

Medtronic, Inc.

Minneapolis , MN

55432

Approval for modifications to the labeling of the SynchroMed EL pumps to increase the shelf life of the 10mL pumps to 24 months and the 18mL pumps to 48 months.

P860004/S067

3/2/05

Special

SynchroMed Programmable Infusion Pumps

Medtronic, Inc.

Minneapolis , MN

55432

Approval for changes to the warning statements of the Technical Manuals for both the SynchroMed EL and SynchroMed II Programmable Infusion Pumps.

P860004/S068

3/10/05

Special

Medtronic Model 8516 Percutaneous Intraspinal Catheter Kit

Medtronic, Inc.

Minneapolis , MN

55432

Approval for a technical manual addendum to be added to the packaged catheter kit to strengthen the instructions for the proper use of the connector.

P870072/S033

3/22/05

180-Day

Thoratec® Ventricular Assist Device (VAD System

Thoratec Corporation

Pleasanton , CA

94588

Approval for a contract sterilization site located at Tri-State Hospital Supply Corporation, Yuma , Arizona and for a change in the cytotoxicity testing process.

P880086/S102

3/8/05

Real-Time

Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval for Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software.

P880087/S011

3/4/05

135-Day

PMMA Single-Piece Anterior Chamber IOL

Alcon Research LTD.

Fort Worth , TX

76134

Approval for the use of an additional supplier of polymethylmethacrylate (PMMA) for the PMMA IOLs.

P890003/S081

3/31/05

Real-Time

Medtronic Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. 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.

P890057/S018

3/10/05

Real-Time

Model 3100B High-Frequency Oscillatory Ventilatory (HFOV)

Bird Products Corporation

Palm Springs , CA

92262

Approval for modifications to the heat and filter on the exhaled gas limb of the existing patient circuit.

P900023/S042

3/23/05

Real-Time

ABIOMED® AB5000™ Circulatory Support System

ABIOMED, Inc.

Danvers , MA

01923

Approval for a change to only the AB5000 Circulatory Support System that will allow the user an alternate means of reducing blood flow during weaning by adjusting the level of vacuum applied to the AB5000 Blood Pump.

P900023/S043

3/11/05

Real-Time

ABIOMED® BVS5000 Bi-Ventricular Support System and AB5000™ Circulatory Support System

ABIOMED, Inc.

Danvers , MA

01923

Approval for the addition of four new inflow cannulae (32/42 Fr Apical Cannula with Side Holes and 32/42 Fr Apical Cannula without Side Holes) for use with the BVS5000 Bi-Ventricular Support System and the AB5000™ Circulatory Support System.

P910023/S076

3/1/05

Real-Time

Epic™ and Epic™+ DR/VR ICD Systems with N2 Capacitor

St. Jude Medical

Sylmar , CA

91342

Approval for the Epic™ and Epic™+ DR/VR ICD Systems with N2 Capacitor.

P910077/S048

3/2/05

Real-Time

Heart Failure PARTNER Model 2936 with software version 1.1

Guidant Corporation

St. Paul , MN

55112

Approval for the Heart Failure PARTNER Model 2936 with software version 1.1 which is indicated for interrogating and downloading diagnostic information obtained by Guidant’s pacemaker and defibrillator Cardiac Resynchronization Therapy (CRT-P and CRT-D) devices.

P920014/S025

3/22/05

180-Day

HeartMate LVAS System

Thoratec Corporation

Pleasanton , CA

94588

Approval for a contract sterilization site located at Tri-State Hospital Supply Corporation, Yuma , Arizona and for a change in the cytotoxicity testing process.

P930016/S020

3/17/05

Panel-Track

STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™)

VISX, Inc.

Santa Clara , CA

95051

Approval for the VISX STAR S4 IR Excimer Laser System with VSS and WaveScan WaveFront System. The device uses a 6.0 mm optical zone, a 9.0 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1.0 to 5.0 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs; 2) in patients 21 years of ago or older; and 3) in patients with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination.

P950015/S010

3/21/05

180-Day

The Heart Laser CO2 TMR System

PLC Medical Systems, Inc.

Franklin , MA

02038

Approval for modifications to the electronic pre-ignition system used by the laser medical device.

P950020/S011

3/8/05

180-Day

Cutting Balloon Monorail (MR)

Boston Scientific

San Diego , CA

92123

Approval for an alternate in-house sterilization site located in Quincy , Massachusetts .

P950020/S012

3/16/05

180-Day

Ultra2 Cutting Balloon Monorail (MR)

Boston Scientific

San Diego , CA

92123

Approval for manufacturing sites located at Interventional Technologies Europe, Ltd., Donegal , Ireland and EBIS Iotron, Ltd., Oxon , Great Britain .

P950039/S014

3/18/05

180-Day

ThinPrep 2000 System

Cytyc Corporation

Marlborough , MA

01752

Approval for a manufacturing site located at Cytyc Corporation, Marlborough , Massachusetts .

P960028/S011

2/23/05

180-Day

Soft Acrylic Multifocal Array® 2 (Models AA40e and AA50) and ReZoom™ (Model NXG1) Intraocular Lenses

Advanced Medical Optics, Inc.

Santa Ana , CA

92705

Approval for Soft Acrylic Multifocal Array® 2 (Models AA40e and AA50) and ReZoom™ (Model NXG1) Intraocular Lenses.

P960040/S051

3/1/05

Real-Time

Vitality™ HE Model T182 Implantable Cardioverter Defibrillator (ICD) System and the Consult Programmer Software Application Model 2896 Version 1.0

Guidant Corporation

St. Paul , MN

55112

Approval for the Vitality HE Model T182 Implantable Cardioverter Defibrillator (ICD) System and the Consult Programmer Software Application Model 2896 Version 1.0. The device is indicated for use as follows: Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular arrhythmias.

P960052S010

3/21/05

Real-Time

High Viscosity DERMABOND® Topical Skin Adhesive

Closure Medical Corporation

Raleigh , NC

27616

Approval for the addition of ProPen and ProPen XL applicators. The device, as modified, will be marketed under the trade names High Viscosity DERMABOND ProPen Topical Adhesive and High Viscosity DERMABOND ProPen XL Topical Skin Adhesive products and are indicated for topical application to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. High Viscosity DERMABOND ProPen and ProPen XL may be used in conjunction with, but not in place of subcuticular sutures. DERMABOND Adhesive may be used in conjunction with, but not in place of deep dermal stitches.

P960058/S040

3/7/05

180-Day

HiResolution™ Bionic Ear System

Advanced Bionics Corporation

Sylmar , CA

91342

Approval for upgrades to the Auria PowerPak™ for the HiRes™ Auria Processor (Behind-the-Ear).

P970051/S028

3/1/05

180-Day

Nucleus 24 Cochlear Implant System

Cochlear Americas

Englewood , CO

80112

Approval for a new receiver/stimulator component (CI24RE), a new speech processor (SP12), the PIF4 Programming Interface, the CS14 Programming Software, and upgraded Neural Response Telemetry Software (EPS5).

P980006/S006

3/17/05

Real-Time

Bausch & Lomb® PureVision™ Toric (balafilcon A) Visibility Tinted Contact Lens

Bausch & Lomb

Rochester , NY

14609

Approval for the toric design with an extended wear indication for up to 30 days continuous wear between removals. The device, as modified, will be marketed under the trade name Bausch & Lomb Pure Vision Toric (balafilcon A) Visibility Tinted Contact Lens and 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, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters that does not interfere with visual acuity. The lens maybe prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00 to -9.00D 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.

P980016/S047

3/31/05

Medtronic Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. 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.

P990001/S017

3/16/05

Real-Time

Vitatron C60 DR (Model C60A3) and Vitatron C20 SR (Model C20A3) Implantable Pulse Generators and their associated software (VSF11/VSF12 version 1.0); and the T-series application software (VSF07/VSF08 version 1.2); and CD-ROM (VSE03/VSE04 version 2.3)

Vitatron

Minneapolis , MN

55432

Approval for the Vitatron C60 DR (Model C60A3) and Vitatron C20 SR (Model C20A3) Implantable Pulse Generators and their associated software (VSF11/VSF12 version 1.0); and the T-series application software (VSF07/VSF08 version 1.2); and CD-ROM (VSE03/VSE04 version 2.3).

P990009/S013

3/10/05

180-Day

FloSeal® Hemostatic Matrix

Baxter Healthcare Corporation

Westlake Village , CA

91362

Approval for an alternate kit configuration that contains a human thrombin component. The device, as modified, will be marketed under the trade name FloSeal® Hemostatic Matrix and is indicated for use in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

P990009/S016

3/31/05

Real-Time

FloSeal® Matrix Hemostatic Agent and FloSeal® Endoscopic Applicator

Baxter Healthcare Corporation

Westlake Village , CA

91362

Approval for a modification to the Endoscopic Applicator and a modification of the “Indication for Use” for the Endoscopic Applicator. The device, as modified, will be marketed under the trade name FloSeal® Endoscopic Applicator and is indicated for use in delivering FloSeal® Matrix Hemostatic Sealant to bleeding surgical sites through a 5 mm or larger trocar.

P990071/S006

3/21/05

Special

Stockert 70 Radiofrequency Ablation Generator

Biosense Webster, Inc.

Diamond Bar , CA

91765

Approval for labeling changes that strengthen the instructions for use.

P000054/S006

3/11/05

Real-Time

InFUSE™ Bone Graft

Medtronic Sofamor Danek

Memphis , TN

38132

Approval for use of new shipping container. The new container is lighter than the current container and uses polystyrene insulation instead of polyurethane.

P000058/S017

3/11/05

Real-Time

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

Medtronic Sofamor Danek

Memphis , TN

38132

Approval for use of new shipping container. The new container is lighter than the current container and uses polystyrene insulation instead of polyurethane.

P010013/S011

3/7/05

180-Day

NovaSure® Impedance Controlled Endometrial Ablation System

Cytyc Surgical Products

Palo Alto , CA

94303

Approval for revised Instructions for Use, including results from the three-year follow up, improved consistency, and a revision to the Contraindications regarding long-term medical therapy.

P010013/S012

3/24/05

180-Day

NovaSure® Global Impendence Controlled Endometrial Ablation System

Cytyc Surgical Products

Palo Alto , CA

94303

Approval for a manufacturing site located at Cytyc Surgical Products, Heredia , Costa Rica .

P010017/S005

3/7/05

180-Day

SensoScan Full Field Digital Mammography System

Fischer Imaging Corporation

Denver , CO

80241

Approval for addition of automatic exposure system, and related changes in Operator’s Manual and QC test and QC Manual under MQSA.

P010031/S019

3/31/05

Real-Time

Medtronic Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the Models 2490G and 2490J CareLink Monitors and Model 2491 DDMA Software for use with the InSync Sentry Model 7297, InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. 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.

P010032/S014

3/4/05

Real-Time

Genesis Neurostimulation System

Advanced Neuromodulation Systems, Inc.

Plano , TX

75024

Approval for the Eon Neurostimulation System, Model 3716, which 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.

P010038/S009

3/7/05

180-Day

Second Look® Digital Computer-aided Detection System

iCAD, Inc.

Beavercreek , OH

45431

Approval for private label distribution (Hologic, Inc. to distribute Second Look®). The device, as modified, will be marketed under the trade name SecurLook™ and is indicated for: The SecurLook™ computer-aided detection system for mammography is intended to identify and mark regions of interest on screening and diagnostic 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 of the original mammogram that may warrant a second review.

P020009/S017

3/9/05

Real-Time

Express/Express 2 ™ Coronary Stent System (Monorail, MR and Over-the-Wire, OTW)

Boston Scientific Corporation

Maple Grove , MN

55311

Approval for modifications to labeling contained in the Warnings/ Precautions sections of the Directions for Use (DFU) and Patient Guides based upon updated safety information related to Magnetic Resonance Imaging (MRI) performed at 3 Tesla.

P020022/S002

3/25/05

Real-Time

Bayer VERSANT HCV RNA 3.0 Assay (bDNA)

Bayer HealthCare LLC

Berkeley , CA

94702

Approval for addition of laboratory information system interface (Version 1.0) to the Bayer System 340 bDNA Analyzer DMS.

P020023/S011

3/11/05

Special

Restylane

Q-Med Scandinavia, Inc.

Princeton , NJ

08540

Approval for changes in product labeling.

P020033/S002

3/15/05

180-Day

INDEPEN-DENCE™ iBOT™ 4000 Mobility System

Independence Technology, L.L.C.

Warren , NJ

07059

Approval for generational changes to the approved device. The device, as modified, will be marketed under the trade name INDEPEN-DENCE™ iBOT™ 4000 Mobility System. The device is indicated for individuals who have mobility impairments and the use of at least on upper extremity. The device is intended to provide mobility on smooth surfaces and inclines at home, at work ,and in other environments; movement across obstacles, uneven terrain, curbs, grass, gravel and other soft surfaces; mobility in a seated position at an elevated height; ascent and decent of stairs with or without assistance; and mobility and transportation.

P020045/S007

3/29/05

Real-Time

7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole System

CryoCath Technologies, Inc.

Quebec , Canada

H9H 5H3

Approval for a modification from temperature to flow control in cryoablation mode of the 7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole.

P030005/S005

3/8/05

180-Day

Guidant CONTAK RENEWAL TR Models H125 and H120

Guidant Corporation

St. Paul , MN

55112

Approval for modified device labeling to describe the COMPANION clinical study.

P030006/S003

3/24/05

180-Day

Celsion Prolieve™ Thermodilatation System

Celsion Corporation

Columbia , MD

21046

Approval of a modified post-approval study for the device.

P030025/S005

3/31/05

180-Day

TAXUS Express2 Coronary Stent System

Boston Scientific Corporation
Maple Grove, MN
55311

Approval to use Steris Isomedix (formerly Cosmed of Rhode Island) as an alternate sterilization site for devices manufactured at Galway, Ireland.

P030006/S004

3/11/05

Real-Time

Prolieve™ Thermodilatation System

Celsion® Corporation

Columbia , MD

21046

Approval for a new ink to be used to mark the catheter component of the device using the same pad printing process for applying these markings.

P030025/S010

3/9/05

Real-Time

TAXUS Express 2 ™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW)

Boston Scientific Corporation

Maple Grove , MN

55311

Approval for modifications to labeling contained in the Warnings/ Precautions sections of the Directions for Use (DFU) and Patient Guides based upon updated safety information related to Magnetic Resonance Imaging (MRI) performed at 3 Tesla.

P030054/S005

3/8/05

Real-Time

Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval for Model 3307 v.4.8.3 and Model 3307 v.4.8.4 Programmer Software.

P030054/S006

3/30/05

Real-Time

Epic, Epic+, and Epic HE ICD Systems

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval for a new capacitor used in the Epic, Epic+, and Epic HE ICD Systems.

P810031/S026

3/4/05

Healon® Sodium Hyaluaronate Viscoelastic Products

Advanced Medical Optics

Santa Ana , CA

92705

Change in vendor of a raw material for Healon® products.

P870025/S007

3/24/05

Corometrics Model 146 Fetal Acoustic Stimulator

GE Medical Systems Information Technologies

Tampa , FL

33614

Change in manufacturer for the plastic housing.

P910073/S050

3/24/05

ENDOTAK® Family (includes ENDOTAK®, ENDOTAK ENDURANCE, ENDOTAK RELIANCE®)

Guidant Corporation

St. Paul , MN

55112

Change to the procedure for inspections of leads with drug subassemblies.

P950001/S014

3/24/05

SELUTE Family (includes SELUTE, SELUTE PICOTIP)

Guidant Corporation

St. Paul , MN

55112

Change to the procedure for inspections of leads with drug subassemblies.

P960004/S028

3/24/05

FINELINE® Family (includes FINELINE®, FINELINE® II)

Guidant Corporation

St. Paul , MN

55112

Change to the procedure for inspections of leads with drug subassemblies.

P960006/S014

3/24/05

SWEET TIP Rx Family (includes SWEET TIP Rx, SWEET PICOTIP Rx, FLEXTEND® Family)

Guidant Corporation

St. Paul , MN

55112

Change to the procedure for inspections of leads with drug subassemblies.

P970051/S030

3/30/05

Nucleus 24 Implant System

Cochlear Americas

Englewood , CO

80112

Change of supplier for three silicone products (Silicone HCRP 50, Silicone LSR 30, and RTV Silicone Adhesive) and change the catalyst in two additional silicone products (MED4515 & MED4516).

P980003/S014

3/1/05

Chilli II Cooled Ablation Catheter, Models M00490310, M0049031K2 and M0049031N4

Boston Scientific Corporation

San Jose , CA

95134

Changes to the solder and adhesive application processes.

P000014/S011

3/29/05

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostics

Rochester , NY

14626

Change to the test and release limit that is applied to the dose-response curve shape parameters.

P000015/S006

3/30/05

Nucleus 24 Auditory Brainstem Implant System

Cochlear Americas

Englewood , CO

80112

Change of supplier for three silicone products (Silicone HCRP 50, Silicone LSR 30, and RTV Silicone Adhesive) and change the catalyst in two additional silicone products (MED4515 & MED4516).

P000032/S006

3/21/05

HerOption™ Cryoablation Therapy System

American Medical Systems

Minnetonka , MN

55343

Addition of a new type of filter to the cryostat, a change to enhance the corrosion resistance of the cryostat tubing and a change in the cryostat cleaning method.

P010012/S043

3/24/05

EASYTRAK® Family (includes EASYTRAK®, EASYTRAK® 2, EASYTRAK® 3)

Guidant Corporation

St. Paul , MN

55112

Change to the procedure for inspections of leads with drug subassemblies.

P010018/S007

3/22/05

Viewpoint™ Conductive Keratoplasty System

Refractec®, Inc.

Irvine , CA

92618

Alternate manufacturing method for the Trocar and Stop subassembly of the disposable Keratoplast tip.

P020008/S001

3/4/05

Karl Storz Autofluorescence System

Karl Storz Endoscopy-America, Inc.

Culver City , CA

90230

Change in the OEM sensor for the Karl Storz Autofluorescence System.