FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

PMA Final Decisions Rendered for August 2005

P030036

8/3/05

SelectSecure™ Lead Model 3830

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the SelectSecure Lead Model 3830. The Model 3830 lead has applications where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. The model 3830 lead is intended for pacing and sensing in the atrium or ventricle.

P040021

8/5/05

SJM Biocor™ Valve and the

SJM Biocor™ Supra Valve

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for the SJM Biocor Valve and the

SJM Biocor Supra Valve.

P040039

8/10/05

Orbasone Pain Relief System

Orthometrix, Inc.

White Plaines, NY

10604

Approval for the Orbasone Pain Relief System. The device is indicated for extracorporeal shock wave therapy for the treatment of chronic proximal plantar fasciitis in patients 18 years of age or older that have failed to respond to conservative therapy. Chronic proximal plantar fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for six months or more.

P040044

8/17/05

Matrix VSG™ System, model MX-1000

AccessClosure, Inc.

Mountain View, CA

94043

Approval for the Matrix VSG™ System, model MX-100. The device is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F, or 7F procedural sheath.

P850020/S020

8/17/05

180-Day

PROSORBA® Protein A Immunoadsorption Column

Fresenius Medical Care North America

Approval for Ethylene Oxide (EO) sterilization site located at Steris Isomedix Services, Inc., Waukegan, Illinois.

P850020/S021

8/25/05

Special

PROSORBA® Column

Fresenius Medical Care North America

Approval for a labeling change to include information on the use of the ART Hemoadsorption System in conjunction with the PROSORBA Column.

P860003/S043

8/19/05

Real-Time

UVAR® XTS™ Photopheresis System

Therakos, Inc.

Exton, PA

19341

Approval for a new centrifuge leak sensor.

P910077/S050

8/15/05

180-Day

Model 3120 ZOOM® Latitude™ Programmer/ Recorder/Monitor, Model 3122 Antenna Accessory, and CONSULT Programmer Software Application Model 2845 Version 4.12

Guidant Corp.

St. Paul, MN

55112

Approval for the addition of a second internal antenna to the Model 3120 ZOOM® Latitude™ Programmer/Recorder/Monitor, a labeling update for the Model 3122 Antenna Accessory, CONSULT Programmer Software Application Model 2845 Version 4.12, and minor manufacturing process changes.

P930016/S021

8/30/05

Panel

STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront ® System

VISX, Inc.

Santa Clara, CA

95051

Approval for the STAR S4 IR™ Excimer Laser System with VSS™ and WaveScan WaveFront® System. The device uses a 6.0 mm optical zone, an 8.0 mm treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of myopia and myopic astigmatism from -6.0 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; 2) in patients 21 years of age or older, and 3) in patients with documented evidence of a change in manifest refraction of no more than 1.00 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination.

P950039/S012

8/5/05

180-Day

ThinPrep 2000 System

Cytyc Corp.

Marlborough, MA

01752

Approval for an addition to the current labeling, with regard to the evaluation of glandular abnormalities using the ThinPrep 2000 System.

P960043/S057

8/11/05

Special

Perclose ProGlide™ 6 French Suture-Mediated Closure (SMC) System

Abbott Laboratories

Redwood City, CA

94063

Approval for revised instructions for use.

P970004/S029

8/4/05

180-Day

Medtronic Interstim® Sacral Nerve Stimulation (SNS)™ System

Medtronic, Inc.

Shoreview, MN

55126

Approval for: 1) shipment of patient cable (Model 041831) after manufacturing to Medtronic Neurological Division, Sullivan Lake Facility, Minneapolis, Minnesota, for cleaning, packaging and ethylene oxide sterilization, 2) extension of the current 2-year shelf life of the patient cable to 4 years using ethylene oxide sterilization and 3) labeling changes that involve combining the separate manuals for the Model 3065U kit and the Model 3057 Lead into one manual and to replace the combined manual for Models 041831, 041829, 041828, 041827 and 041826 with separate single sheet IFUs (information for use).

P980016/S053

8/19/05

Real-Time

RAMware (Baseline 15 with Inc5 RAMware) update to the Medtronic EnTrust 30J/35J ICD Systems

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the RAMware (Baseline 15 with Inc5 RAMware) update to the Medtronic EnTrust 30J/35J ICD Systems for the following Models: Medtronic® EnTrust Model D153ATG;

Medtronic® EnTrust Model D153DRG;

Medtronic® EnTrust Model D153VRC;

Medtronic® EnTrust Model D154ATG;

Medtronic® EnTrust Model D154DRG; and

Medtronic® EnTrust Model D154VRC.

P980022/S012

8/24/05

180-Day

Guardian RT

Medtronic MiniMed

Northridge, CA

91325

Approval for modifications to the sensor to include the use of human serum albumin in place of bovine serum albumin as a stabilizer and a change to the manufacturing process removing the outer hydrophilic membrane.

P000009/S016

8/11/05

Real-Time

Lumos VR-T and Lumos DR-T Implantable Cardioverter Defibrillators with 502.U ICS Programmer Software, A-K00.4.U EPR/ TMS Programmer Software, and Home Monitoring Version 1.7.1

Biotronik, Inc.

Lake Oswego, OR

97035

Approval to implement intracardiac electrogram (IEGM) snapshots of tachycardia events into Home Monitoring transmissions. In order to accomplish this, you have requested the approval of the Lumos family of ICDs programmer software upgrades, and an upgrade to the currently marketed Home Monitoring Service Center.

P000029/S012

8/2/05

180-Day

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Approval for modification of the post approval study protocol to:

1) replace the 1- and 5-year voiding cystourethrogram measurements with clinical assessments of “febrile UTI;”and 2) decrease the total sample size from 200 to 149 patients.

P000046/S011

8/3/05

Special

Shellgel™ Sodium Hyaluronate

Anika Therapeutics, Inc.

Woburn, MA

01801

Approval for the change in labeling to include cannula assembly instructions and four addition languages.

P000054/S003

8/22/05

135-Day

INFUSE® Bone Graft

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for the addition of a raw material supplier.

P000058/S014

8/22/05

135-Day

INFUSE® Bone Graft/LT CAGE® Lumbar Tapered Fusion Device

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for the addition of a raw material supplier.

P010012/S044

8/15/05

180-Day

CONTAK RENEWAL 3 RF CRT-D Models H210/H215/H250/ H255; CONTAK RENEWAL 3 RF CRT-D Models H217/H219/ H257/259; CONTAK RENEWAL 3 RF HE Pulse Generator Software Version 1.2; and CONSULT programmer Software Application Model 2845 Version 4.12

Guidant Corporation

St. Paul, MN

55112

Approval for CONTAK RENEWAL 3 RF Pulse Generator Software Version 1.2 and CONSULT Programmer Software Application Model 2845 Version 4.12. Also approval to replace the existing Polyimide tubing that provides insulation in the pulse generator header assembly with Polyetheretherke-tone (PEEK) tubing.

P010012/S056

8/16/05

Real-Time

CONTAK RENEWAL Model H135; CONTAK RENEWAL 3 Models H170, H173

& H175; CONTAK RENEWAL 3 HE Models H177 & H179; CONTAK

RENEWAL 3 RF Models H210, H215, H250 & H255; CONTAK RENEWAL 3

RF HE Models H217, H219, H257, & H259; CONSULT Programmer Software Application Model 2845 Version 4.12

Guidant Corporation

St. Paul, MN

55112

Approval for 1) An alternate magnetic reed switch manufactured by Hermetic and an associated change to the equipment used in the rework of this component (only in CONTAK RENEWAL 3 RF Models H210, H215, H250 & H255 and CONTAK RENEWAL 3 RF HE Models H217, H219, H257, & H259); and

2) CONSULT Programmer Software Application Model 2845 Version 4.12.

P010015/S013

8/12/05

180-Day

InSync Registry

Medtronic, Inc.

Minneapolis, MN
55432

Approval to incorporate CRT devices with defibrillator capabilities (CRT-D into the InSync Registry.

P010021/S006

8/11/05

135-Day

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Approval for extension of shelf-life and bioburden for a manufacturing component.

P030017/S008

8/18/05

180-Day

PRECISION™ Spinal Cord Stimulation (SCS) System

Advanced Bionics

Sylmar, CA

91342

Approval for Artisan 2 X 8 Paddle Lead, Model SC-8116-xx.

P040043/S006

8/31/05

180-Day

GORE TAG Thoracic Endoprosthesis

W.L. Gore and Associates

Flagstaff, AZ

86001

Approval of the post-approval study protocol.

P880081/S031

8/4/05

AMO Silicone Monofocal and Multifocal Intraocular Lens

Advanced Medical Optics, Inc.

Santa Ana, CA

92705

Change in the outer IOL box.

P880086/S105

8/25/05

Affinity, Identity, Integrity, and Frontier family of Devices

St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Addition of a spot laser weld to the resistance weld that bonds the feedthrough wire to the connector wire.

P880086/S106

8/25/05

Affinity, Identity, Integrity, and Frontier family of Devices

St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Change of the manual epoxy dispensing method to a semi-automated robot controlled epoxy dispensing system.

P910073/S052

8/3/05

RELIANCE ACTIVE FIX and Passive FIX Steroid Eluting Endocardial Defibrillation Lead

Guidant Corporation

St. Paul, MN

55112

Addition of a sight hole in one side of the electrode base.

P910073/S053

8/31/05

Reliance Leads

Guidant Corporation

St. Paul, MN

55112

Addition of helix inspection criteria to the manufacturing instructions.

P930038/S045

8/31/05

Angio-Seal

St. Jude Medical Daig Division, Inc.

Minnetonka, MN

55345

Change to use the semi-automated Back Half Machine System.

P960006/S016

8/4/05

FLEXTEND Family of Pacing Leads

Guidant Corporation

St. Paul, MN

55112

Addition of primer to the inner surface of the electrode ring of the FLEXTEND leads to increase adhesion of the electrode ring to the molded neck.

P960006/S017

8/31/05

Flextend Leads

Guidant Corporation

St. Paul, MN

55112

Addition of helix inspection criteria to the manufacturing instructions.

P960028/S014

8/4/05

AMO Silicone Monofocal and Multifocal Intraocular Lens

Advanced Medical Optics, Inc.

Santa Ana, CA

92705

Change in the outer IOL box.

P990045/S008

8/29/05

ETI-AB-COREK PLUS

DiaSorin S.p.A

Saluggia, Italy

13040

Change in determination of specific attributes of quality control for a raw reagent.

P000037/S007

8/25/05

On-X® Prosthetic Heart Valve

MCRI, Inc.

Austin, TX

78754

Change in manufacturing for the On-X valve that entails a family of changes to CMM software and related procedures.

P000044/S007

8/8/05

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

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Change in raw reagent supplier and material specifications.

P010012/S054

8/4/05

CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillator (CRT-D), Models H135, H170, H175, H177, and H179

Guidant Corporation

St. Paul, MN

55112

Change in test software for the CONTAK RENEWAL CRT-D

Devices per routine procedures.

P010012/S059

8/25/05

Contak Renewal Models H170, H175, H177, H179, H210, H215, H217, H219, H250, H255, H257, H259

Guidant Corporation

St. Paul, MN

55112

Addition of a stiffener fixture and flux dispense to the rework process.

P030025/S022

8/31/05

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System

Boston Scientific Cardiovascular

Maple Grove, MN

55311

Removal of a “Pesticide Residue Test”from the incoming raw material specification for toluene used in the stent coating process.