PMA Final Decisions Rendered for May 2005

P030049

5/26/05

ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur® HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur® HBsAg Quality Control Material

Bayer Healthcare, Diagnostics Div.

Tarrytown , NY

10591

Approval for the ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur® HBsAg Confirmatory ReadyPack

Reagents, and ADVIA Centaur® HBsAg Quality Control Material: ADVIA Centaur HBsAg Ready Pack Indications for Use: The ADVIA Centaur HBsAg assay is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur® system. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infections. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. ADVIA Centaur HBsAg Confirmatory Ready Pack Indication for use: The ADVIA Centaur® HBsAg Confirmatory assay is an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, lithium or sodium heparin) using the ADVIA Centaur® system. The assay is intended to be used to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur HBsAg assay. ADVIA Centaur® HBsAg Quality Control Material Indications for Use: for monitoring the performance of the HBsAg and HBsAg Confirmatory assays on the ADVIA Centaur® Systems.

P040005

5/3/05

DakoCytomation Her2 FISH pharmDX™ Kit

DakoCytomation Denmark A/S.

Glostrup , Denmark

DK-2600

Approval for the DakoCytomation Her2 FISH pharmDX™ Kit. The device is indicated for: The DakoCytomation Her2 FISH pharmDX™ Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine the Her2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Her2 FISH pharmDX™ Kit is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered. Results form the Her2 FISH pharmDx™ Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node positive breast cancer patients.

P040023

5/3/05

Duraloc® Option Ceramic Hip System

DePuy Orthopedics, Inc.

Warsaw , IN

46581

Approval for the Duraloc® Option Ceramic Hip System. The device is indicated for non-cemented use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis.

P790019/S019

5/25/05

Special

Abbott HAVAB®

-M EIA

Abbott Laboratories

Abbott Park , IL

60064

Approval for change in quality controls that add a new specification, or otherwise provide additional assurance of purity, identity, strength, or reliability of the Abbott HAVAB®

-M EIA assay.

P860019/S201

5/11/05

135-Day

Maverick2™ Monorail and Maverick Over-the-Wire PTCA Catheters

Boston Scientific

Maple Grove , MN

55311

Approval for change in the manufacturing process for forming the folding the balloon wings from a manual process to an automated process.

P900056/S084

5/25/05

Special

Rotablator Rotational Angioplasty System

Boston Scientific Corp.

Maple Grove , MN

55311

Approval for an additional quality control (QC) inspection method using the passage of guidewire through the RotaLink PLUS device lumen to verify the device is free from obstructions.

P910023/S078

5/24/05

Real-Time

Housecall Plus™ Transtelephonic Monitoring System with Model 3180-R Receiver Software (Version 2.1)

St. Jude Medical

Sunnyvale , CA

94086

Approval for the software modifications to the St. Jude Medical Housecall Plus™ Receiver software (version 2.1).

P920004/S020

5/19/05

180-Day

VasoSeal® On-Site Precision Closure Device

Datascope Corporation

MahWah , NJ

07430

Approval for the VasoSeal® On-Site Precision Closure Device.

P930016/S022

5/2/05

Real-Time

STAR S4 IR™ Excimer Laser System

VISX, Inc.

Santa Clara , CA

95051

Approval for software and labeling changes regarding the iris registration functionality of the device.

P930038/S042

5/16/05

135-Day

Angio-Seal™ Vascular Closure Device

St. Jude Medical, Inc.

Minnetonka , MN

55345

Approval for an alternative backup deployment rest methodology.

P930038/S043

5/12/05

Real-Time

Angio-Seal™ Vascular Closure Device

St. Jude Medical, Inc.

Minnetonka , MN
55345

Approval for changing the lot release sampling plan and performance specification.

P950014/S025

5/25/05

Real-Time

Urologix Prostatron™ System

Urologix

Minneapolis , MN

55447

Approval to modify a voltage tolerance setting and to replace the current software with its previously approved version.

P950022/S019

5/16/05

Real-Time

Riata® Defibrillation Leads

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval for changes to the stylet ring and the lead header coupling.

P950037/S035

5/18/05

180-Day

Implant Control System (ICS) 3000

Biotronik, Inc.

Lake Oswego , OR 97035

Approval for the Implant Control System (ICS) 3000 pacemaker programming system, using software Version 402.U.

P960040/S053

5/18/05

Real-Time

Vitality™ HE Model T180 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 T180 Implantable Cardioverter Defibrillator (ICD) System and the Consult Programmer Software Application Model 2896 Version 1.0. The device is indicated as follows: Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

P970004/S032

5/27/05

Special

Medtronic® InterStim® Sacral Nerve Stimulation™ System

Medtronic, Inc.

Shoreview , MN

55126

Approval for the addition of a precaution statement to the technical manual of the Model 8840 N’Vision Programmer regarding the presence of flammable anesthetic agents.

P980003/S015

5/20/05

Real-Time

Chilli II Cooled Ablation Catheters

Boston Scientific Corporation

San Jose , CA

95134

Approval for an extension of the shelf life from six (6) months to on (1) year; and, packaging changes for the Chilli® II Ablation Catheter.

P980006/S007

5/27/05

180-Day

BAUSCH & LOMB® PureVision™ (balafilcon A) Visibility Tinted Contact Lens for Therapeutic Use

Bausch & Lomb

Rochester , NY

14609

Approval for adding a therapeutic indication for the PureVision Contact Lens. The device, as modified, will be marketed under the trade name BAUSCH & LOMB® PureVision™ (balafilcon A) Visibility tinted Contact Lens for Therapeutic Use and is indicated for therapeutic use as a bandage contact lens for corneal protection and corneal pain relief during treatment of ocular pathologies as well as post-surgical conditions. Applications of the PureVision Contact Lens include but are not limited to conditions such as the following:

1) For corneal protection in conditions such as entropion, trichiasis, tarsal scars, recurrent corneal erosion and post surgical ptosis for corneal protection; 2) For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, post-keratoplasty;

3) For use as a bandage during the healing process of conditions such as chronic epithelial defects, corneal ulcer, neurotrophic keratitis, neuroparalytic keratitis, chemical burns, and post surgical epithelial defects; and

4) For post surgical conditions that include bandage use such as LASIK, PRK, PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical conditions. Pure Vision Contact Lenses for therapeutic use can also provide correction during healing if required.

P980006/S008

5/27/05

Real-Time

BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lenses

Bausch & Lomb

Rochester , NY

14609

Approval for a multifocal design of the BAUSCH & LOMB® PureVision™ Visibility Tinted Contact Lenses 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) and presbyopia 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 +6.00D to -18.00D when prescribed for up to 30 days of extended wear and from +20.00 to

-20.00 for daily wear or extended wear up to 7 days with add powers ranging from +0.75 to +5.00D.

P980053/S009

5/25/05

180-Day

Durasphere® Injectable Bulking Agent

Carbon Medical Technologies, Inc.

St. Paul , MN

55110

Approval for inclusion of the 5-year post-market study information in the Directions for Use.

P990004/S008

5/5/05

Real-Time

Surgiflo Hemostatic Matrix

Johnson & Johnson Wound Management

Somerville , NJ

08876

Approval for marketing a pre-filled paste prepared from the powdered form of the absorbable gelatin sponge. The device, as modified, will be marketed under the trade name SURGIFLO Hemostatic Matrix and is indicated for surgical procedures (except urologic and ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.

P990066/S019

5/25/05

Real-Time

Senographe DS Full Field Digital Mammography System

GE Healthcare

Waukesha , WI

53188

Approval for changes in two software modifications that have been made to the acquisition workstation (AWS) and for an additional supplier for the conditioner (chiller for the image receptor). The device, as modified, will be marketed under the trade name Senographe DS Full Field Digital Mammography System and is indicated as follows: The Senographe DS Full Field Digital Mammography System generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Senographe DS Full Field Digital Mammography System is intended to be used in the same clinical applications as traditional film-based mammographic system.

P000044/S006

5/5/05

Special

VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit

Ortho-Clinical Diagnostic, Inc.

Rochester , NY

14626

Approval for changes in the manufacturing process which add an incoming raw material test.

P010014/S002

5/27/05

Real-Time

Oxford Meniscal Unicompartmental Knee System

Biomet Manufacturing Corp.

Warsaw , IN

46581

Approval for design modifications to the tibial baseplate.

P010032/S013

5/11/05

Real-Time

S-Series Lamitrode Leads

Advanced Neuromodulation Systems, Inc.

Plano , TX

75024

Approval for the addition of four models of the S-Series Lamitrode Leads as accessories to the Genesis family of Neurostimulation IPG devices. The device, as modified, will be marketed under the trade name S-Series Lamitrode leads (model numbers3243, 3246, 3283 and 3286) and is indicated for use as the lead component of a spinal cord stimulation system. The spinal cord stimulation system is used to aid in the management of chronic pain of the trunk and/or extremities.

P010032/S016

5/5/05

Real-Time

Genesis Dual

4-Channel Implantable Pulse Generator (IPG), Model 3643

Advanced Neuromodulation Systems, Inc.

Plano , TX

75024

Approval for the Genesis Dual

4-Channel Implantable Pulse Generator (IPG), Model 3643 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.

P020004/S010

5/10/05

135-Day

GORE EXCLUDER® Bifurcated Endoprosthesis, Contralateral Leg Component, Trunk-Ipsilateral Leg Component, Aortic Extender Component and Iliac Extender Component

W.L. Gore & Associates, Inc.

Flagstaff , AZ

86001

Approval for the addition of a new cleanroom and controlled environment area.

P020026/S011

5/20/05

180-Day

CYPHER Sirolimus-eluting Coronary Stent

Cordis Corporation
Miami Lakes, FL
33014

Approval for an analytical testing laboratory located at Pharmaceutical Sourcing Group Americas (PSGA), also known as Janssen Pharmaceuticals, Inc., Titusville, New Jersey.

P020031/S001

5/25/05

180-Day

Microsulis Microwave Endometrial Ablation (MEA) System

Microsulis Medical Ltd.

Denmead Hampshire, UK

PO7 6XP

02451

Approval for the single use MEA applicator.

P030024/S003

5/5/05

Special

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Approval for the addition of an incoming raw material test.

P030025/S007

5/19/05

Real-Time

TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation

Natick , MA

01760

Approval for extension of the product shelf life from 9 months to 12 months.

P030030/S002

5/27/05

180-Day

Bard® Tegress™ Urethral Implant

C.R. Bard, Inc.

Covington , GA

30014

Approval for a manufacturing site at Bard Shannon Ltd., Las Piedras, Puerto Rico , 00771.

P030034/S001

5/16/05

Real-Time

Cervical-Stim® Cervical Fusion System

Orthofix, Inc.

McKinney , TX

75069

Approval for the following modifications:

1) The Power Source has been changed from a 9 volt disposable lithium battery to an 11.1 volt rechargeable lithium battery. 2) The user interface has been changed from three color LED indicators to a Liquid Crystal Display. 3) The drive circuit and microprocessor were previously located on separate pc boards. The modified device incorporates both components on the same pc board. 4) Optional Accessory: Personal Data Assistant (PDA) for Orthofix personal use only. 5) The connection between the device and the compliance printer has changed from a serial port cable to an infrared port. The device, as modified, will be marketed under the trade name Cervical-Stim® Model 2505 and is indicated for: “The Cervical-Stim® Model 2505 Cervical Fusion System is a noninvasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.”

P860057/S028

5/20/05

Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900, 2900P (PERIMOUNT Plus™), 6900PTFX

Edwards Lifesciences LLC

Irvine , CA

92614

Change in the supplier of polyethylene terephthalate (PET) polyester yarn and knitted polyester fabric.

P870056/S021

5/20/05

Carpentier-Edwards® Bioprosthesis, Models 2625, 6625

Edwards Lifesciences LLC

Irvine , CA

92614

Change in the supplier of polyethylene terephthalate (PET) polyester yarn and knitted polyester fabric.

P870077/S019

5/20/05

Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625LP, 6625-ESR-LP

Edwards Lifesciences LLC

Irvine , CA

92614

Change in the supplier of polyethylene terephthalate (PET) polyester yarn and knitted polyester fabric.

P900009/S020

5/19/05

Exogen 2000+ Sonic Accelerated Fracture Healing System (SAFHS) and Exogen 3000 Sonic Accelerated Fracture Healing System (SAFHS)

Smith & Nephew, Inc.

Memphis , TN

38116

Addition of a new contract vendor for the supply of components/ materials used in the manufacturing process.

P910023/S079

5/9/05

St. Jude ICDs

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Alternate process for removing epoxy from the connector block threaded bores of the ICD devices.

P950022/S020

5/5/05

Riata Family of Defibrillation Leads

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Dimensional changes to the Riata leads.

P950022/S021

5/5/05

Riata Family of Defibrillation Leads

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Change from welding to crimping connectors.

P950022/S022

5/5/05

Riata Family of Defibrillation Leads

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Change from manual to automated processing.

P950022/S023

5/5/05

Riata Family of Defibrillation Leads

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Change in the order of manufacturing steps for the crimping process.

P960006/S015

5/6/05

FLEXTEND Leads, Models 4086, 4087, and 4088

Guidant Corporation

St. Paul , MN

55112

Change of silicone adhesive.

P980049/S019

5/13/05

Alto SHOCK 4 Modules

ELA Medical, Inc.

Plymouth , MN

55441

Changes to the manufacturing process at International Rectifier, Leominster , Massachusetts and Thales, Neuilly-sur-Seine , France . The modifications include: 1) changing the epoxy resin for encapsulation

2) removing the Parylene coating

3) changing the photocoupler and discharge circuits form separate components to a single component coated with epoxy 4) changing the epoxy for attaching the transformer, and 5) adding a silicone cover over certain capacitors prior to the final assembly process.

P000007/S008

5/20/05

Edwards Prima Plus Stentless Bioprosthesis, Model 2500, 2500P

Edwards Lifesciences LLC

Irvine , CA

92614

Change in the supplier of polyethylene terephthalate (PET) polyester yarn and knitted polyester fabric.

P000014/S012

5/25/05

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Change in scale of reagent manufacturing.

P000032/S009

5/26/05

Her Option™ Cryoablation Therapy System

American Medical Systems

Minnetonka , MN

55343

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

P000037/S004

5/4/05

On-X® Prosthetic Heart Valve

MCRI

Austin , TX

78754

Change in the manufacturing process to include an additional standard leaflet inspection step for reworked product with unacceptably high leak test result.

P010041/S008

5/20/05

Carpentier-Edwards® Supraannular (S.A.V.®) Bioprosthesis, Model 2650, 6650

Edwards Lifesciences LLC

Irvine , CA

92614

Change in the supplier of polyethylene terephthalate (PET) polyester yarn and knitted polyester fabric.

P030012/S001

5/25/05

R2 ImageChecker CT CAD Software System

R2 Technology, Inc.

Sunnyvale , CA

94087

Alternate manufacturing process for the R2 ImageChecker CT product lines.

P030054/S009

5/9/05

St. Jude ICDs

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Alternate process for removing epoxy from the connector block threaded bores of the ICD devices.

P040043/S001

5/10/05

GORE TAG Thoracic Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff , AZ

86001

Addition of a new cleanroom and controlled environment area.

P040043/S002

5/20/05

GORE TAG Thoracic Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff , AZ

86001

Change from a hand assembly process to a semi-automated process in the assembly of the delivery catheter.

P040043/S003

5/27/05

GORE TAG Thoracic Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff , AZ

86001

Expansion of the controlled manufacturing environment at Woody Springs .

P040043/S004

5/27/05

GORE TAG Thoracic Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff , AZ

86001

Expansion of the controlled manufacturing environment at Elk Hill.