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

PMA Final Decisions Rendered for April 2005

P030037

4/29/05

Rithron-XR Coronary Stent System

BIOTRONIK, Inc.

Lake Oswego , OR

97035

Approval for the Rithron-XR Coronary Stent System. The device is indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic heart disease characterized by discrete de novo coronary artery lesions with reference vessel diameter from ≥3.0 mm or ≤4.0 mm and target lesion length ≤20.0 mm.

P040016

4/12/05

Boston Scientific Corporation Liberté™ Monorail™ and Over-the-Wire Coronary Stent Systems

Boston Scientific Corporation

Maple Grove , MN

55311

Approval for the Boston Scientific Corporation® Liberté™ Monorail™ and Over-the-Wire Coronary Stent Systems. The devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease with stenotic lesions in native coronary arteries (length <=28 mm) with a reference vessel diameter of 2.75 to 5.00 mm.

P040026

4/1/05

Orthospec™ Extracorporeal Shock Wave Therapy Device

Medispec, Ltd.

Germantown , MD

20874

Approval for the Orthospec Extracorporeal Shock Wave Therapy Device. The device is indicated for the treatment of Proximal Plantar Fasciitis with or without heel spur in patients 18 years of age or older. The Orthospec™ extracorporeal shock wave therapy is a non-invasive alternative method for patient with symptoms of Proximal Plantar Fasciitis for 6 months or more and a history of unsuccessful conservative therapies to relieve heel pain. Proximal Plantar Fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the plantar calcaneal tuberosity.

P040034

4/7/05

DuraSeal™ Dural Sealant System

Confluent Surgical, Inc.

Waltham , MA

02451

Approval for the DuraSeal™ Dural Sealant System. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. DuraSeal should only be used with autologous duraplasty material.

P810044/S005

4/8/05

180-Day

Diabetes Sentry

Diabetes Sentry Products, Inc.

Bellingham , WA

98225

Approval for the change of the device web address, and a change to the name of the device. The device, as modified, will be marketed under the trade name Diabetes Sentry.

P840001/S074

4/8/05

180-Day

Restore™ Rechargeable Neurostimulation System

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the Restore™ Rechargeable Neurostimulation System which is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) Failed Back Syndrome or Low Back Syndrome or Failed Back; 2) Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome; 3) Post Laminectomy Pain; 4) Unsuccessful Disk Surgery; 5) Degenerative Disk Disease (DDD)/Herniated Disk pain refractory to conservative and surgical interventions; 6) Peripheral Causalgia; 7) Epidural Fibrosis; 8) Arachnoiditis or Lumbar Adhesive Arachnoiditis; 9) Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and 10) Multiple Back Surgeries.

P840001/S075

4/15/05

180-Day

Itrel 3, Synergy and Synergy Versitrel

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the 1 x 8 Lead System.

P840001/S077

4/15/05

180-Day

Synergy Plus+™ (Model 7479) and Synergy Compact+™ (Model 7479B) Neurostimulation Systems

Medtronic Neurological

Minneapolis , MN

55432

Approval for the Synergy Plus+™ (Model 7479) and Synergy Compact+™ (Model 7479B) Neurostimulation Systems which are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) Failed Back Syndrome or Low Back Syndrome or Failed Back; 2) Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome; 3) Post Laminectomy Pain; 4) Unsuccessful Disk Surgery; 5) Degenerative Disk Disease (DDD)/Herniated Disk pain refractory to conservative and surgical interventions; 6) Peripheral Causalgia; 7) Epidural Fibrosis; 8) Arachnoiditis or Lumbar Adhesive Arachnoiditis; 9) Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and 10) Multiple Back Surgeries.

P840064/S027

4/12/05

Real-Time

DisCoVisc™ Ophthalmic Viscosurgical Device

Alcon Research Ltd.

Forth Worth, TX

76134

Approval for the addition of a 1.0 ml fill size to the product line.

P850007/S027

4/5/05

180-Day

Physio-Stim Models 3202, 3302, 3313, 3314, 3315 and

Spinal-Stim Model 2212

Orthofix, Inc.

McKinney , TX

75069

Approval to modify the Physio-Stim Lite, Models 202L, 303L, 215L, 313L, 314L and Spinal-Stim Models 212L and 212LE as follows: 1) change the power source from a 9-volt disposable battery to an 11.1-volt rechargeable; 2) change the user interface from a three color LED to a backlit LCD display; 3) change the circuit assembly from separate boards for the drive circuit and microcontroller to a single board; 4) add an optional personal data assistant (PDA) that may be used to set daily shutdown time for Orthofix personnel use only; and 5) change the serial port cable on the compliance printer to an infrared port. The devices, as modified, will be marketed under the trade names Physio-Stim Models 3202, 3302, 3313, 3314, 3315 and

Spinal-Stim Model 2212. The Physio-Stim Models are indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defects is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The Spinal-Stim is a noninvasive electromagnetic bone growth stimulator indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since last surgery.

P860004/S069

4/7/05

Real-Time

SynchroMed II Pump

Medtronic Neurological

Minneapolis , MN

55432

Approval for the pump head cover assembly modifications, roller arm and support assembly modifications and shaft assembly modifications.

P860057/S023

4/7/05

Real-Time

Carpentier-Edwards® Perimount® Pericardial Bioprosthesis, Models 2700TFX, 2800TFX (Perimount® RSR), 6900PTFX (Perimount Plus®), and 3000TFX (Perimount Magna®)

Edwards Lifesciences LLC

Irvine , CA

92614

Approval for extension of the shelf life from one to two years.

P880086/S103

4/6/05

Real-Time

Pre-molded Header Connector design for the Integrity DR Model 5336, Identity DR Model 5370, Identity ADx DR Model 5380, Identity ADx VDR Model 5480, and Integrity ADx DR Model 5360

St. Jude Medical

Sylmar , CA

91342

Approval for pre-molded header design. The device, as modified, will be marketed under the trade names Integrity DR Model 5336, Identity DR Model 5370, Identity ADx DR Model 5380, Identity ADx VDR Model 5480, and Integrity ADx DR Model 5360.

P900060/S030

4/8/05

135-Day

CarboMedics Prosthetic Heart Valve

CarboMedics, Inc.

Austin , TX

78752

Approval for a change in the lock wire fabrication for the CarboMedics Prosthetic Heart Valve.

P910066/S020

4/13/05

180-Day

OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators

dj Orthopedics, LLC

Vista , CA

92081

Approval for a manufacturing site located at dj Orthopedics, LLC, Vista , California .

P940031/S034

4/8/05

Real-Time

Seal Plug Lubricant (MED-420) for Guidant Heart Failure, Tachy and Brady Devices

Guidant Corporation

St. Paul , MN

55112

Approval for the use of a lubricant on seal plugs of the Heart Failure, Tachy and Brady devices.

P940040/S005

4/22/05

180-Day

AMPLICOR Mycobacterium tuberculosis Test

Roche Molecular Systems, Inc.

Pleasanton , CA

94566

Approval for a manufacturing site located at Roche Molecular Systems, Inc., Sommerville , New Jersey , for kit packaging and staging activities.

P950029/S022

4/27/05

180-Day

Symphony DR 2550 Mode and Elaview 1.28 UG1 Programming Software

ELA Medical, Inc.

Plymouth , MN

55441

Approval for the AAIsafeR2 pacing mode and the Elaview 1.28 UG1 programming software. The device, as modified, will be marketed under the trade name Symphony DR 2550 and is indicated for: 1) Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. 2) The accepted patient conditions warranting chronic cardiac pacing which include, but are not restricted to: symptomatic paroxysmal or permanent second or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias and vasovagal syndromes or hypersensitive carotid sinus syndromes. In addition, the dual-chamber and atrial tracking modes is indicated for patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony which include: various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

P960030/S012

4/27/05

180-Day

IsoFlex P Lead Family Models 1644T and 1648T steroid eluting, passive fixation endocardial pacing leads

St. Jude Medical, Inc.

Sylmar , CA

91342

Approval for the addition of a polyurethane insulator. The devices, as modified, will be marketed under the trade names IsoFlex P 1644T and IsoFlex P 1648T leads and are indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (model 1644T) or ventricle (model 1648T).

P960040/S052

4/8/05

Real-Time

Seal Plug Lubricant (MED-420) for Guidant Heart Failure, Tachy and Brady Devices

Guidant Corporation

St. Paul , MN

55112

Approval for the use of a lubricant on seal plugs of the Heart Failure, Tachy and Brady devices.

D970003/S032

4/8/05

Real-Time

Seal Plug Lubricant (MED-420) for Guidant Heart Failure, Tachy and Brady Devices

Guidant Corporation

St. Paul , MN

55112

Approval for the use of a lubricant on seal plugs of the Heart Failure, Tachy and Brady devices.

P970003/S057

4/29/05

Special

VNS Therapy System with Model 250 Programming Software Version 7.0 “Instruction Card”

Cyberonics, Inc.

Houston , TX

77058

Approval for text changes to the printed Instruction Card.

P970008/S027

4/29/05

Real-Time

Targis™ System

Urologix, Inc.

Minneapolis , MN

55447

Approval for upgrading a Targis™ control board (Luxtron sub-assembly).

P970020/S046

4/21/05

Real-Time

Multi- Link® RX and OTW

Coronary Stent Systems; Multi-Link® HP RX and OTW Coronary Stent Systems; Multi-Link Duet™ RX and OTW Coronary Stent Systems; Multi-Link Tristar™ RX and OTW Coronary Stent Systems; Multi-Link Ultra™ RX and OTW Coronary Stent Systems; Multi-Link Tetra™ RX and OTW Coronary Stent Systems; Multi-Link Penta® RX and OTW Coronary Stent Systems; Multi-Link Pixel® RX and OTW Coronary Stent Systems; and Multi-Link Zeta® RX and OTW Coronary Stent Systems.

Guidant Corporation/ Vascular Intervention

Temecula , CA

92591

Approval to update the IFU to revise the MRI statement.

P970051/S031

4/13/05

Real-Time

Nucleus 24 Cochlear Implant System

Cochlear Americas

Englewood , CO

80112

Approval for an optional body-worn battery pack and controller (BWBP) for use with the SP12 Speech Processor.

P980035/S038

4/28/05

180-Day

Medtronic Model P1501DR EnRhythm Implantable Pulse Generator, Medtronic Model 9987 Application Software and Medtronic Model 2696 InCheck Patient Assistant

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the Medtronic Model P1501DR EnRhythm™ Implantable Pulse Generator, Medtronic Model 9987 Application Software and Medtronic Model 2696 InCheck™ Patient Assistant. The device is indicated for the following: 1) Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. 2) Accepted patient conditions warranting chronic cardiac pacing which include: symptomatic paroxysmal or permanent second or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders and bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.

P990080/S006

4/13/05

Real-Time

TECNIS Foldable Acrylic Intraocular Lens Model ZA9003

Advanced Medical Optics, Inc.

Santa Ana , CA

92799

Approval for the TECNIS Foldable Acrylic Intraocular Lens Model ZA9003 with claims regarding reduction in postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance.

P000009/S014

4/28/05

Real-Time

Xelos DR-T ICD System and Application software version A-K00.3.U

BIOTRONIK, Inc.

Lake Oswego , OR

97035

Approval for the Xelos DR-T ICD System and Application software version A-K00.3.U. The device, as modified, will be marketed under the trade name Xelos DR-T ICD System and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

P000010/S004

4/22/05

180-Day

AMPLICOR HCV Test, version 2.0

Roche Molecular Systems, Inc.

Pleasanton , CA

94566

Approval for a manufacturing site located at Roche Molecular Systems, Inc., Sommerville , New Jersey , for kit packaging and staging activities.

P000012/S005

4/22/05

180-Day

COBAS AMPLICOR HCV Test, version 2.0 and COBAS AmpliPrep/COBAS AMPLICOR HCV Test, version 2.0

Roche Molecular Systems, Inc.

Pleasanton , CA

94566

Approval for a manufacturing site located at Roche Molecular Systems, Inc., Sommerville , New Jersey , for kit packaging and staging activities.

P000054/S004

4/20/05

Real-Time

INFUSE™ Bone Graft

Medtronic Sofamor Danek

Memphis , TN

38132

Approval for two changes to the processing of the rhBMP-2 component of the device – the use of a new working cell bank and the use of a longer hold-time (≤120 hours at 2-8 º C compared to the current 24 hours) for the Matrex Cellufine Sulfate column.

P000054/S005

4/20/05

135-Day

INFUSE™ Bone Graft

Medtronic Sofamor Danek

Memphis , TN

38132

Approval for a new reference standard for the rhBMP-2 component.

P000058/S009

4/20/05

Real-Time

INFUSE™ Bone Graft/LT-Cage Lumbar Tapered

Fusion Device

Medtronic Sofamor Danek

Memphis , TN

38132

Approval for two changes to the processing of the rhBMP-2 component of the device – the use of a new working cell bank and the use of a longer hold-time (≤120 hours at 2-8 º C compared to the current 24 hours) for the Matrex Cellufine Sulfate column.

P000058/S016

4/20/05

135-Day

INFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device

Medtronic Sofamor Danek

Memphis , TN

38132

Approval for a new reference standard for the rhBMP-2 component.

P010012/S045

4/8/05

Real-Time

Seal Plug Lubricant (MED-420) for Guidant Heart Failure, Tachy and Brady Devices

Guidant Corporation

St. Paul , MN

55112

Approval for the use of a lubricant, MED-420 on seal plugs of the Heart Failure, Tachy and Brady devices.

P010031/S018

4/8/05

180-Day

Medtronic® InSync® III Marquis Model 7279 with Model 9989 Application Software, Medtronic® InSync® Maximo Models 7303 and 7304 with Model 9998 Application Software, Medtronic® InSync® Sentry Models 7297 and 7299 with Model 9998 Application Software

Medtronic, Inc.

Minneapolis , MN

55432

Approval for the Medtronic® InSync® III Marquis Model 7279 with Model 9989 Application Software, Medtronic® InSync® Maximo Models 7303 and 7304 with Model 9998 Application Software, Medtronic® InSync® Sentry Models 7297 and 7299 with Model 9998 Application Software. The devices are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤-5% and a prolonged QRS duration.

P020026/S010

4/15/05

Real-Time

CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System

Cordis Corporation

Miami , FL

33102

Approval for modifications to the CYPHER™ Sirolimus-Eluting Coronary Stent System (CYPHER Stent) Instructions for Use (IFU).

P030005/S008

4/8/05

Real-Time

Seal Plug Lubricant (MED-420) for Guidant Heart Failure, Tachy and Brady Devices

Guidant Corporation

St. Paul , MN

55112

Approval for the use of a lubricant on seal plugs of the Heart Failure, Tachy and Brady devices.

P030035/S003

4/29/05

Panel

Frontier™ Model 5508L and Frontier™ II Model 5586 Cardiac Resynchronization Therapy Pacemakers (CRT-P) supported on the Model 3510 programmer platforms with the Model 3307, v4.8m programmer software

St. Jude Medical

Sylmar , CA

91342

Approval for the Frontier™ Cardiac Resynchronization Therapy System. These devices are indicated for:

1) Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure.

2) The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤35% and a prolonged QRS duration.

P030050/S001

4/11/05

180-Day

Sculptra

Dermik Laboratories

Berwyn , PA

19312

Approval of the post-approval study for the device.

P030054/S004

4/11/05

180-Day

Quicksite® 1056T Left Ventricular Pacing Lead

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval for the Quicksite 1056T Left Ventricular Pacing Lead.

P810046/S219

4/26/05

VOYAGER™ RX Coronary Dilatation Catheter

Guidant Corporation

Temecula , CA

92591

Change in the trimming process of the inner member of the catheter.

P860004/S071

4/29/05

Synchromed II, Implantable Infusion Pump System

Medtronic, Inc.

Minneapolis , MN

55432

Changes to the hybrid test suite to add a marching RAM test for the microprocessor’s onboard RAM.

P860057/S027

4/8/05

Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX,

2800, 2800TFX, 3000, 3000TFX, 6900, 6900P (PERIMOUNT Plus™)

Edwards Lifesciences LLC

Irvine , CA

92614

Change to the supplier of polytetrafluoroethylene (PTFE) yarn and thread.

P870056/S020

4/8/05

Carpentier-Edwards® Bioprosthesis, Models 2625, 6625, Valved Conduit Model 4300

Edwards Lifesciences LLC

Irvine , CA

92614

Change to the supplier of polytetrafluoroethylene (PTFE) yarn and thread.

P870077/S018

4/8/05

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

Edwards Lifesciences LLC

Irvine , CA

92614

Change to the supplier of polytetrafluoroethylene (PTFE) yarn and thread.

P950032/S040

4/25/05

Apligraf

Organogenesis, Inc.

Canton , MA

02021

Changes to the formulation of the trypsin quenching solution used in the Apligraf manufacturing process.

P960009/S032

4/27/05

Kinetra Model 7428 Implantable Neurostimulation System

Medtronic, Inc.

Minneapolis , MN

55432

Modification for the epoxy disperse pattern of the wire bond.

P970054/S002

4/1/05

Parvovirus B19 IgG Enzyme Immunoassay

Hogan & Hartson, L.L.P.

Washington , DC

20004

Change in the manufacture of Control material.

P970055/S002

4/1/05

Parvovirus B19 IgM Enzyme Immunoassay

Hogan & Hartson, L.L.P.

Washington , DC

20004

Change in the manufacture of Control material.

P000007/S007

4/8/05

Edwards Prima Plus Stentless Bioprosthesis, Model 2500P

Edwards Lifesciences LLC

Irvine , CA

92614

Change to the supplier of polytetrafluoroethylene (PTFE) yarn and thread.

P000032/S008

4/22/05

Her Option™ Cryoablation Therapy System

American Medical Systems

Minnetonka , MN

55343

Change in the joining operations for the Her Option™ Cryoablation Therapy System.

P010012/S046

4/14/05

RENEWAL® Pulse Generators

Guidant CRM

St. Paul , MN

55112

Hybrid fabrication to also be performed in Clonmel , Ireland .

P010041/S007

4/8/05

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

Edwards Lifesciences LLC

Irvine , CA

92614

Change to the supplier of polytetrafluoroethylene (PTFE) yarn and thread.

P030017/S006

4/8/05

Precision® Spinal Cord Stimulator System

Advanced Bionics

Sylmar , CA

91342

Change in the manufacturing process to propose an alternate supplier of the Precision® System Lead and Lead Extensions.

P030025/S018

4/13/05

TAXUS™ Express 2 ™ Paclitaxel-Eluting Coronary Stent System

Boston Scientific

Maple Grove , MN

55311

Alternative analytical method to be used for the non-compendial functional excipient analysis of Poly (styrene-isobutylene-styrene) Tri-Block Copolymer, SIBS in the TAXUS™ Express 2 ™ Paclitaxel-Eluting Coronary Stent System.

P030026/S005

4/15/05

Vitros Immunodiagnostics Products Anti-HBc IgM Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Modification in testing of incoming material.