P040028

3/16/06

LUMA Cervical Imaging System

MediSpectra, Inc.

Lexington, MA

02421

Approval for the LUMA Cervical Imaging System. The device is indicated for use as an adjunct to colposcopy for the identification of high-grade disease (CIN 2, 3+) in women referred to colposcopy with a Pap test result of atypical squamous cells (ASC), low-grade squamous intraepithelial lesion (LSIL) or high-grade squamous intraepithelial lesion or cancer (HSIL+).

P040052

3/3/06

MonoPrep Pap Test (MPPT)

MonoGen, Inc.

Vernon Hills, IL

60061

Approval for the MonoPrep Pap Test (MPPT). The device is intended for use in collecting and preparing cervical-vaginal cytology specimens for Pap stain-based screening for cervical cancer, it's precursor lesions, and other cytological categories and conditions defined by The 2001 Bethesda System: terminology for reporting results of cervical cytology. The MonoPrep Pap Test produces slides that are intended to replace conventionally prepared Pap smear slides.

P050012

3/24/06

DexCom STS Continuous Glucose Monitoring System

DexCom, Inc.

San Diego, CA

92121

Approval for the DexCom STS Continuous Glucose Monitoring System. The device is indicated for the following:

1) Indicated for detecting trends and tracking patterns in adults (18 and older) with diabetes and is intended for use by patients at home and in health care facilities. The device is for prescription use.

2) Indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. 3) Aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the STS System results should be based on the trends and patterns seen with several sequential sensor readings over time.

P820003/S078

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P820018/S074

3/14/06

180-Day

Aurora/Quadra, Reflex, Simplex and Meta Pacemakers

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P830045/S093

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P830045/S094

3/14/06

180-Day

Paragon, Phoenix, Multilog and Sensorithm Pacemakers

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P830045/S095

3/7/06

Real-Time

All Pacemaker, CRT-P, CRT-D and ICD Models

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for the Model 3330 Version 2.0 Software for use on the Model 3650 Merlin Patient Care System.

P830055/S096

3/22/06

Special

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for an additional in-process inspection of the patella flange thickness for the Sigma P.F.C. RPF femoral components.

P840001/S089

3/17/06

Real-Time

Model 37701 RestorePRIME Implantable Neurostimulator (INS)

Medtronic Neurological

Minneapolis, MN

55432

Approval for the Model 37701 RestorePRIME Implantable Neurostimulator (INS).

P840001/S090

3/31/06

Real-Time

Restore Implantable Neurostimulation System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 37082 Dual Quadripolar Extension Kit (8-2-4).

P850051/S062

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P860004/S076

3/27/06

180-Day

SynchroMed II Programmable Drug Pump

Medtronic Neurological

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico.

P860004/S078

3/10/06

Real-Time

SynchroMed Implantable Infusion System: Percutaneous Intraspinal Catheter Kit

Medtronic Neurological

Minneapolis, MN

55432

Approval for inclusion of the B. Braun Medical Perifix Catheter Connector in the Model 8516 Percutaneous Intraspinal Catheter Kit.

P860004/S079

3/22/06

180-Day

SynchroMed Implantable Pump System

Medtronic Neurological

Minneapolis, MN

55432

Approval for revised labeling for the manuals for the device.

P860004/S081

3/22/06

Real-Time

Model 8709 & 8731 Catheters

Medtronic Neurological

Minneapolis, MN

55432

Approval for the following changes: 1) adding a sutureless pump connector to both Models 8709 and 8731 catheters compatible with the SynchroMed and IsoMed implantable infusion pumps;

2) adding numbers (in centimeters) to the markings on the 8709 catheter body like those on the 8731 catheter;

3) adding a shorter (9.3 cm) introducer needle to the Model 8731 kit; 4) adding connector pins and strain relief sleeves to Model 8731 catheter kit allowing the pump segment of the catheter to be trimmed;

5) create Model 8578 as a revision kit for 8709 or 8709SC (sutureless connector) containing the sutureless connector segment and strain relief sleeves;

6) adding Model 8598A for current 8598 kit (8731 spinal catheter segment revision kit) modified to contain the shorter (9.3 cm) introducer needle; and 7) Model 8596SC as the pump connector in the current 8596 kit (8731 pump catheter segment revision kit) was replaced with the sutureless pump connector.

P860004/S082

3/30/06

Real-time

SynchroMed II Programmable Drug Infusion System

Medtronic Neurological

Minneapolis, MN

55432

Approval for the following modification: 1) shortening length of bulkhead inlet feature by 0.8 mm (0.03149 inches) from 3.0 mm to 2.2 mm; and 2) increasing radius of outer wall of bulkhead electronic chamber pocket by 0.3 mm (0.0118 inches) from 34.5 mm (1.358264 inches to 34.8 mm (1.370075 inches).

P860057/S032

3/24/06

Real-Time

Carpentier-Edwards PERIMOUNT Pericardial Biorosthesis, Models 2700TFX, 2800 TFX, 3000TFX and 6900PTFX

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for protocols to be used to extend the shelf life beyond the current 2 years.

P870025/S008

3/2/06

135-Day

Fetal Acoustic Stimulator (FAST) - Corometrics Model 146

GE Medical Systems Information

Technologies

Tampa, FL

33614

Approval for vendor changes for the following components: die cast frame and printed circuit board (PCB) and a change in adhesive material.

P880006/S036

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P880006/S037

3/14/06

180-Day

Regency, Sensolog III, and Dialog II Pacemakers

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P880006/S038

3/7/06

Real-Time

P880086/S113

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P880086/S114

3/14/06

180-Day

Solus, Addvent, Solus II, Synchrony, Phoenix III, Trilogy, Affinity, Integrity, Entity, Identity, Verity and Victory Pacemakers

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P880086/S115

3/7/06

Real-Time

All Pacemaker, CRT-P, CRT-D and ICD Models

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for the Model 3330 Version 2.0 Software for use on the Model 3650 Merlin Patient Care System.

P890003/S100

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P900022/S006

3/15/06

Real-Time

CPR3 Programming Head for Chorus Models 6001, 6003, 6004, 6033, and 6034

ELA Medical, Inc.

Plymouth, MN 55441

Approval for the hardware modification of the CPR3 programming head to be used with all the ELA's ICD and pacemaker systems.

P900060/S032

3/30/06

180-Day

CarboMedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, and Carbo-Seal Valsalva Ascending Aortic prosthesis; Models 500, R500, S500, 700, S700, F500, F700, 100 and 200

CarboMedics

Austin, TX

78752

Approval for a manufacturing site located at Sorin Group Canada, Inc., Mitroflow Division, Burnaby, British Columbia, Canada, to be used to assemble the sewing cuff.

P900061/S062

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P900070/S031

3/14/06

180-Day

Meta and Tempo Pacemakers

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P910023/S088

3/14/06

180-Day

Epic II VR, Epic II DR, and Epic II+ DR Implantable Cardioverter Defibrillators (Models V-158, V-255, V-258) and Model 3307 v.6.0m Software

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P910023/S092

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P910023/S100

3/7/06

Real-Time

All Pacemaker, CRT-P, CRT-D and ICD Models

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for the Model 3330 Version 2.0 Software for use on the Model 3650 Merlin Patient Care System.

P930022/S004

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P950022/S027

3/7/06

Real-Time

Riata ST Models 7000, 7001, 7002, 7010, 7011, & 7012

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for: 1) modifications to the

Riata ST Models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical adhesive used for shock coil backfill. 2) modifications to the Riata ST Models 7000, 7001, and 7002 leads to create an active-fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names Riata ST Models 7010, 7011, and 7012 and are indicated for use with compatible pulse generators. 3) modifications to the Riata ST Models 7000, 7001, and 7002 to create a passive fixation and a passive fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names Riata ST Models 7040, 7041 and 7042 (passive fixation) and Riata ST Models 7050, 7051, 7052 (passive fixation integrated bipolar) and are indicated for use with compatible pulse generators.

P950022/S028

3/7/06

Real-Time

Riata ST Passive Lead Models 7040, 7041, 7042, 7050, 7051 & 7052

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for: 1) modifications to the

Riata ST Models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical adhesive used for shock coil backfill. 2) modifications to the Riata ST Models 7000, 7001, and 7002 leads to create an active-fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names Riata ST Models 7010, 7011, and 7012 and are indicated for use with compatible pulse generators. 3) modifications to the Riata ST Models 7000, 7001, and 7002 to create a passive fixation and a passive fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names Riata ST Models 7040, 7041 and 7042 (passive fixation) and Riata ST Models 7050, 7051, 7052 (passive fixation integrated bipolar) and are indicated for use with compatible pulse generators.

P950029/S025

3/15/06

Real-Time

CPR3 Programming Head for Chorus RM Model 7034; Opus RM Model 4534; Brio Models 112, 212, 220, 222; Talent 113, 213, 223; Opus G 4621, 4624; Talent II Models 133, 233; Symphony 2250, 2550; and ELA Rhapsody 2530, 2510, 2210

ELA Medical, Inc.

Plymouth, MN 55441

Approval for the hardware modification of the CPR3 programming head to be used with all the ELA's ICD and pacemaker systems.

P960009/S036

3/2/06

Real-Time

Medtronic Activa Deep Brain Stimulation (DBS) Systems Models 3387S, 3389S DBS Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for modifications to the Model 3387/3389 DBS Lead Kit intended for use with the Medtronic implantable systems for DBS. The modifications specified were: to remove the percutaneous extension, to add a lead cap, and to bundle the Medtronic Image-Guided Neurologics StimLoc Kit (burr hole cover assembly) with the DBS Lead Kit.

P960009/S037

3/1/06

Special

Medtronic Activa Deep Brain Stimulation (DBS), Model 7424 Itrell II Neurostimulator (DBS applications only), Model 7426 Soletra Neurostimulator, Model 7428 Kinetra Neurostimulator, Models 3387 & 3389 DBS Leads, Models 7582 & 7495 DBS Extensions

Medtronic, Inc.

Minneapolis, MN

55432

Approval for minor modifications to the labeling with respect to the MRI (magnetic resonance imaging) instructions; and for removing the “MRI and Activa Therapy”appendix from the labeling and replacing it with a stand-alone MRI guidelines document.

P960043/S058

3/31/06

Special

Prostar XL 8 & 10F PVS System

Abbott Laboratories

Redwood City, CA

94063

Approval for revised instructions for use.

P960058/S053

3/22/06

Special

HiResolution Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for a modification to the Electrostatic Discharge (ESD) precaution in the HiResolution Bionic Ear System Package Insert.

P970008/S029

3/23/06

180-Day

Urologix Targis System

Urologix, Inc.

Minneapolis, MN

55447

Approval for the addition of a radio frequency identification (RFID) system to prevent reuse of the disposable device components. The device, as modified, will be marketed under the trade name Urologix Targis System and is indicated for the delivery of microwave energy to the prostate for the treatment of BPH in a single session. It is indicated for patients with prostatic lengths of 30 to 50 mm.

P970008/S030

3/20/06

180-Day

Urologix Targis System

Urologix, Inc.

Minneapolis, MN

55447

Approval for upgrades to the TargisSystem. These changes include improved appearance (which required replacing the Control Unit exterior panels and moving the user controls), improved electromagnetic compatibility (EMC), and other component and manufacturing modifications due to component obsolescence.

P970012/S021

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P970013/S003

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P970013/S004

3/14/06

180-Day

Microny Pacemakers

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P970013/S005

3/7/06

Real-Time

All Pacemaker, CRT-P, CRT-D and ICD Models

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for the Model 3330 Version 2.0 Software for use on the Model 3650 Merlin Patient Care System.

P970030/S006

3/31/06

Special

St Jude Medical Toronto SPV Valve, Model SPA-101

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for changes to the Instruction for Use to add and strengthen cautions in the use of the device.

P980016/S066

3/2/06

Real-Time

Marquis DR/VR Models 7274, 7230B, 7230CX, 7230E; Maximo DR/VR Models 7278, 7232, 7232B, 7232E; Intrinsic Model 7288; Intrinsic 30J Model 7287; EnTrust 30J/35J ICD (D153ATG, D153DRG, D153VRC, D154ATG, D154 DRG, D154VRC)

Medtronic, Inc.

Shoreview, MN

55126

Approval for a change in hybrid components, the accelerometer (XE407) and tantalum capacitor (XT122) for the products previously listed.

P980016/S067

3/2/06

Real-Time

Medtronic EnTrust 30J/35J ICD Family Models D153ATG, D153DRG, D153VRC, D154ATG, D154DRG and D154VRC

Medtronic, Inc.

Shoreview, MN

55126

Approval for a minor design change to the ICR (Interconnect Ribbon) that connects the feedthroughs to the connector module blocks and multi beam contacts for the Medtronic EnTrust 30J/35J ICD Family (D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC). Specifically, the interconnect ribbon (ICR) that connects the feedthroughs to the connector module blocks and multi beam contacts is being modified to provide a lap-weld joint and the bonding of the same materials.

P980016/S070

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P980035/S050

3/2/06

135-Day

Implantable Pulse Generator, Model AT501

Medtronic, Inc.

Shoreview, MN

55126

Approval for changes to the SRAM.

P980035/S054

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P980049/S022

3/15/06

Real-Time

CPR3 Programming Head for Defender II Model 9201; Defender IV Model 612; Alto Models 614 and 615; and Alto 2 Models 624 and 625

ELA Medical, Inc.

Plymouth, MN 55441

Approval for the hardware modification of the CPR3 programming head to be used with all the ELA's ICD and pacemaker systems.

P980050/S021

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P990001/S024

3/31/06

Real-Time

Vitatron C60 DR Model C60A3, Vitatron C20 SR Model C20A3, Vitatron T60 DR Model T60A1, and Vitatron T20 SR Model T20A1

Vitatron

Shoreview, MN

55123

Approval for software revisions.

P990001/S025

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P990020/S020

3/17/06

180-Day

AneuRx AAAdvantage stent Graft with Xcelerant Delivery System

Medtronic Vascular

Santa Rosa, CA

95403

Approval for additional iliac sizes (including 18mm and 20mm diameters; flared iliac and iliac cuffs in 16 mm x 20mm, 18mm x 22mm, and 18mm x 24mm); a longer aortic body of the bifurcated component by 1 cm; pre-shaped (contoured) stent rings; and Platinum-iridium radiopaque markets. The device, as modified, will be marketed under the trade name AneuRx AAAdvantage Stent Graft with Xcelerant Delivery system and is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal, non-aneurysmal, neck length of greater than 1 cm at the proximal and distal ends of the aneurysm and an inner vessel diameter approximately 10-20% smaller than the labeled device diameter; 3) Morphology suitable for endovascular repair; 4) One of the following: aneurysm diameter > 5 cm; aneurysm diameter of 4-5 cm which has also increased in size by 0.5 cm in the last 6 months; or aneurysm which is twice the diameter of the normal infrarenal aorta.

P990025/S011

3/28/06

Real-Time

QwikStar Navigation/Ablation Catheter

Biosense Webster, Inc.

Palos Verdes Estates, CA

90274

Approval for a minor labeling revision for the 4 mm QwikStar Diagnostic/Ablation Catheter to include the NOGA XP Navigation System as an optional mapping system for the QwikStar catheter. The device, as modified, will be marketed under the same trade name and is indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radio-frequency generators in adults and children four years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used in the CARTO XP EP or NOGA XP Navigation Systems, the QwikStar Diagnostic/Ablation Catheter provides location information and approximate catheter tip curvature.

P990027/S007

3/15/06

180-Day

Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction

Bausch & Lomb, Inc.

Rochester, NY

14609

Approval for: 1) an increase in the laser pulse repetition frequency from the current 50 Hz to 100 Hz; 2)replacement of the CeraTube Midi v.4.1 laser with the CeraTube Midi v.5.2 laser; 3) software revisions to accommodate the new laser and pulse rate; 4) labeling changes to document these modifications.

P990034/S006

3/22/06

180-Day

IsoMed Implantable Pump System

Medtronic Neurological

Minneapolis, MN

55432

Approval for revised labeling for the manuals for the device.

P990050/S006

3/28/06

180-Day

WavSTAT Optical Biopsy System

SpectraScience, Inc.

San Diego, CA

92121

Approval for a manufacturing site located at SpectraScience, Inc., San Diego, California.

P000029/S016

3/1/06

Special

Deflux Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Approval for a quality control change resulting in additional assurance of the purity of the devices.

P000043/S014

3/28/06

180-Day

TherMatrx TMx-2000 BPH Thermotherapy System

American Medical Systems

Minnetonka, MN

55343

Approval for a transfer of packaging site of the rectal probes to American Medical Systems, Minnetonka, Minnesota and to generate package labels in house.

P010014/S001

3/23/06

180-Day

Oxford Meniscal Unicompartmental Knee System

Biomet Manufacturing Corporation

Warsaw, IN

46581

Approval of the post-approval study for the device.

P010014/S004

3/31/06

135-Day

Oxford Meniscal Unicompartmental Knee System

Biomet Manufacturing Corporation

Warsaw, IN

46581

Approval for a change in sterilization validation method from AAMI/IOS 11137 Method 1 to AAMI TIR 27.

P010014/S008

3/15/06

Real-Time

Oxford Meniscal Unicompartmental Knee System

Biomet Manufacturing Corporation

Warsaw, IN

46581

Approval for a product line extension to include a series of extra-small components (femoral, meniscal bearing, tibial tray) and a new series of anatomic (left and right specific) meniscal bearing components.

P010015/S016

3/7/06

180-Day

InSync III Biventricular Pacing System (Model 8041)

Medtronic, Inc.

Shoreview, MN

55126

Approval for modifications to the device labeling to describe the CARE-HF clinical study. Medtronic also requests a reformatting of the indications statement and the addition of a Clinical Outcomes section to the device labeling which includes claims based on the primary endpoint and two secondary endpoints in the CARE-HF study. The Medtronic InSync III Model 8042 is indicated for NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction = 35% and a prolonged QRS duration. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

P010015/S021

3/31/06

Real-Time

All Medtronic Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P010025/S008

3/29/06

180-Day

Selenia Full field Digital Mammography System

Hologic, Inc.

Bedford, MA

01730

Approval for an optional product configuration of tungsten target with rhodium and silver filters in the x-ray system instead of molybdenum target with molybdenum and rhodium filters.

P010031/S034

3/2/06

Real-Time

InSync III Marquis Model 7279 ; InSync Sentry Models 7297, 7299 ; InSync II Marquis Model 7289 ; InSync II Protect Model 7295; InSync III Protect Model 7285; InSync Maximo Models 7303, 7304 ; InSync Marquis Models 7277

Medtronic, Inc.

Shoreview, MN

55126

Approval for a change in hybrid components, the accelerometer (XE407) and tantalum capacitor (XT122) for the products previously listed.

P010031/S037

3/31/06

Real-Time

All Medtronic and Vitatron Pacemaker and ICD Models

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Model 9986 Desktop/BOSS (software version 1.5.1) for the Medtronic Model 2090 CareLink Programmer for All Medtronic pacemaker and ICD models. It is to enhance internal

P010033/S010

3/10/06

Special

QuantiFERON-TB Gold

Cellestis, Inc.

Valencia, CA

91355

Approval for labeling change to the wording of the interpretation of the test to remove ambiguity and enhance safe use.

P020018/S007

3/23/06

180-Day

Zenith Flex AAA Endovascular Graft with the H&LB One-Shot

Cook, Inc.

Bloomington, IN

47402

Approval of the post-approval study submission for the Zenith Flex AAA Endovascular Graft with the H&LB One-Shot.

P020035/S002

3/3/06

Real-Time

X-Site Suture-Mediated Closure Device

Datascope Corporation

Mahwah, NJ

07430

Approval for various labeling changes and ergonomic changes to the device. The device, as modified, will be marketed under the trade name X-Site Suture-Mediated Closure Device and is indicated for “…the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional coronary catheterization procedures using sheaths less than or equal to 6 Fr. The X-Site Suture-Mediated Closure Device is intended to reduce the time to h0mostasis, time to ambulation (100 feet), and time to dischargeability in patients who have undergone diagnostic or interventional coronary catheterization procedures without complicating clinical conditions, including those receiving Glycoprotein IIb/IIIa inhibitors.”

P030002/S006

3/3/06

180-Day

crystaLens Model AT-45 Accommodating Intraocular Lens (IOL)

Eyeonics, Inc.

Aliso Viejo, CA

92656

Approval for updated physician labeling with 3-year clinical data.

P030006/S008

3/31/06

180-Day

Celsion Prolieve Thermodilatation System

Celsion Corporation

Columbia, MD

21046

Approval for software revisions and modification of the device operating system to Embedded Windows XP

P030006/S009

3/15/06

180-Day

Celsion Prolieve Thermodilatation System

Celsion Corporation

Columbia, MD

21046

Approval for multiple design modifications which affect the safety and effectiveness of the Prolieve device.

P030035/S006

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P030035/S007

3/14/06

180-Day

Frontier and Frontier II Biventricular Pacing Systems

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P030035/S008

3/7/06

Real-Time

All Pacemaker, CRT-P, CRT-D and ICD Models

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for the Model 3330 Version 2.0 Software for use on the Model 3650 Merlin Patient Care System.

P030035/S010

3/2/06

Real-Time

Frontier II Device Model 5586

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for a new analog chip for use in the St. Jude Medical Frontier II device model 5586.

P030039/S003

3/10/06

Special

CoSeal Surgical Sealant

Baxter Healthcare Corporation

McGaw Park, IL

60085

Approval for labeling change to add a warning regarding use of the sealant to adhere objects to tissue.

P030054/S019

3/14/06

180-Day

Epic II HF Cardiac Resynchronization Therapy Defibrillator (Model V-355) and Model 3307 v.6.0m Software

St. Jude Medical, CRMD

Sunnyvale, CA

94086

Approval for modifications to the Epic II/Epic II+ and Epic II HF devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names Epic II/Epic II+ DR/VR/HF Implantable Cardioverter Defibrillator Systems (Models V-158, V-255, V-258, and V-355) and Model 3307 v. 6.0c Software. The Model 3307 v. 6.0m software interfaces with the above noted PMAs. The devices are indicated as follows:

The Epic II and Epic II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For Epic II+ DR devices, AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, the Epic II HF system is also intended: 1)to provide a 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 (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

P030054/S020

3/2/06

Real-Time

Generator and Implantable Cardioverter Defibrillator (ICD) Families

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for Model 3330 Version 1.2 software supporting the Microny/Regency and Frontier devices on the Model 3650 Merlin Programmer.

P030054/S022

3/7/06

Real-Time

All Pacemaker, CRT-P, CRT-D and ICD Models

St. Jude Medical, CRMD

Sylmar, CA

91342

Approval for the Model 3330 Version 2.0 Software for use on the Model 3650 Merlin Patient Care System.

P040006/S002

3/29/06

180-Day

CHARIT Artificial Disc

DePuy Spine, Inc.

Raynham, MA

02767

Approval for 1) new endplates coated with vacuum plasma-sprayed pure titanium and calcium phosphate; 2) three new intermediate endplate sizes utilizing this same coating; and 3) various surgical instruments to accommodate the proposed new endplates.

P040012/S003

3/16/06

180-Day

ACCULINK Carotid Stent System and RX ACCULINK Carotid Stent System

Guidant Corporation

Santa Clara, CA

95054

Approval of modifications to the protocol for the ARCHER Long Term Follow-up (LTFU) Trial. The revised protocol includes measures designed to assist in the recruitment and evaluation of patients, and complies with the conditions of approval outlined in the August 30, 2004 approval order for P040012.

P040012/S008

3/27/06

Special

ACCULINK and RX ACCULINK Carotid Stent System

Guidant Corporation

Santa Clara, CA

95054

Approval for the following changes: 1) Addition of a new catheter leak test to the manufacturing process; 2) Modifications to the radio force in-process testing parameters; 3) Increasing the stringency of the AQL for the distal junction test; 4) Addition of a microscopic visual inspection step to detect broken struts; and 5) Addition of an inspection step to verify that the adhesive was correctly applied and completely cured.

P040012/S010

3/14/06

Real-Time

ACCULINK and RX ACCULINK Carotid Stent System

Guidant Corporation

Santa Clara, CA

95054

Approval for removal of stent mass as a final product specification for the RX ACCULINK Carotid Stent System and modification of the specifications regarding allowable contaminant in the device packaging.

P040013/S002

3/27/06

Real-Time

GEM 21S (Growth-factor Enhance Matrix)

Biomimetics Therapeutics, Inc.

Franklin, TN

37067

Approval for expiry date of 24 months and is indicated to treat the following periodontally related defects:

1) Intrabony periodontal defects 2) Furcation periodontal defects, and 3) Gingival recession associated with periodontal defects.

P040024/S005

3/3/06

Special

Restylane Injectable Gel

Medicis Aesthetics Holdings, Inc.

Scottsdale, AZ

85258

Approval for quality control change that provides for additional assurance of the purity of Restylane Injectable Gel device regarding endotoxin level.

N16837/S004

3/2/06

Artegraft Collagen Vascular Graft

Artegraft, Inc.

North Brunswick, NJ

08902

Addition of an alternate supplier for the Bovine Carotid Artery component of the device.

P800022/S054

3/22/06

Zyderm Zyplast Collagen Implant, CosmoDerm/ CosmoPlast Human Collagen Implant

Inamed Corporation

Santa Barbara, CA

93111

Change of component supplier.

P810025/S025

3/14/06

Amvisc and Amvisc Plus

Bausch and Lomb

San Dimas, CA

91773

Removal of the chloroform treatment step from the manufacturing process for the Amvisc and Amvisc Plus.

P860019/S207

3/2/06

Percutaneous Transluminal Coronary Angioplasty Catheters Maverick 2 Monorail, PTCA Catheters and NC Monorail PTCA Catheter

Boston Scientific Corporation

Maple Grove, MN

55311

Modification of the equipment nozzle to the mold used for making the manifold of the above-stated devices.

P910023/S101

3/14/06

Epic/Epic+ and Atlas/Atlas+ Family of Pulse Generators

St. Jude Medical, CRMD

Sylmar, CA

91342

Change from a manual to an automated system for the soldering of the output flex to feedthru subassemblies on the devices.

P940031/S051

3/31/06

PULSAR/

DISCOVERY/

MERIDIAN

Guidant Corp.

St. Paul, MN

55112

Addition of a requirement for the thickness of the gold plating on the accelerometer bond pad for the devices.

P960004/S034

3/9/06

ThinLine/ FINELINE Leads

Guidant Corporation

St. Paul, MN

55112

Use of Automatic Vision System for inspecting the presence of coil weld.

P960013/S016

3/2/06

Tendril Model 1488T/TC and 1688T/TC Leads

St. Jude Medical, CRMD

Sylmar, CA

91342

Addition of an inspection for medical adhesive on the helix during production.

P960013/S017

3/2/06

Tendril Model 1488T/TC and 1688T/TC Leads

St. Jude Medical, CRMD

Sylmar, CA

91342

Addition of an additional crimp depth measurement and record on the manufacturing traveler during production.

P960040/S109

3/31/06

VENTAK Family

Guidant Corp.

St. Paul, MN

55112

Moving the process of applying polyimide over the brazed joints from Guidant to the telemetry coil supplier.

P960040/S111

3/31/06

VENTAK AV/VR/PRIZM

Guidant Corp.

St. Paul, MN

55112

Addition of a requirement for the thickness of the gold plating on the accelerometer bond pad for the devices.

P960040/S112

3/31/06

VENTAK Family

Guidant Corp.

St. Paul, MN

55112

Change to the operator handling/cleaning instructions.

P960040/S113

3/31/06

VENTAK AV/VR/PRIZM

Guidant Corp.

St. Paul, MN

55112

Change from laser etching to laser oxidizing for the marking process for pulse generator cans.

D970003/S061

3/14/06

INSIGNIA/NEXUS Family of Implantable Pacemaker Devices

Guidant Corporation

St. Paul, MN

55112

Addition of an alternate supplier for the C2 component for the device.

D970003/S063

3/31/06

INSIGNIA, NEXUS

Guidant Corp.

St. Paul, MN

55112

Addition of a requirement for the thickness of the gold plating on the accelerometer bond pad for the devices.

D970003/S065

3/31/06

INSIGNIA Family of Pacemakers

Guidant Corp.

St. Paul, MN

55112

Addition of an automated inspection process to an existing manual inspection process.

D970003/S066

3/31/06

INSIGNIA and NEXUS Pacemakers

Guidant Corp.

St. Paul, MN

55112

Change in vendors for INSIGNIA and NEXUS telemetry coils.

P980016/S069

3/9/06

Marquis, Maximo, InSync, Entrust, and Intrinsic Family of Implantable Cardioverter Defibrillators (ICDs)

Medtronic, Inc.

Shoreview, MN

55126

Addition of an in-process Quality Assurance (QA) test to the Final Functional Testing.

P980053/S010

3/15/06

Durasphere Injectable Bulking Agent

Carbon Medical technologies, Inc.

St. Paul, MN

55110

Modification to the pouch sealing parameters.

P990040/S002

3/7/06

TRUFILL n-Butyl Cyanoacrylate (nBCA) Liquid Embolic System

Cordis Neurovascular

Miami Lakes, FL

33014

Change in the immediate product container to eliminate the white background paint from the aluminum tube containing the product.

P990040/S003

3/7/06

TRUFILL n-Butyl Cyanoacrylate (nBCA) Liquid Embolic System

Cordis Neurovascular

Miami Lakes, FL

33014

Change in the dry-heat sterilizer to one of higher capacity.

P000013/S006

3/14/06

Trident Ceramic-on-Ceramic Acetabular System

Stryker Howmedica Osteonics Corp.

Mahwah, NJ

07430

Manufacturing process changes by CeramTec, Inc. for the Biolox forte ceramic femoral heads and inserts.

P010012/S104

3/24/06

CONTAK RENEWAL RF Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Guidant Corp.

St. Paul, MN

55112

Changes to the manufacturing test software.

P010012/S105

3/14/06

RENEWAL Family of CRT-Ds

Guidant Corp.

St. Paul, MN

55112

Change from a manual to an automated visual inspection of digital dies.

P010012/S106

3/31/06

CONTAK CD/EASYTRAK Family

Guidant Corp.

St. Paul, MN

55112

Change to the placement requirement for the inner seal for the device.

P010012/S107

3/31/06

CONTAK CD Family of CRT-Ds

Guidant Corp.

St. Paul, MN

55112

Moving the process of applying polyimide over the brazed joints from Guidant to the telemetry coil supplier.

P010012/S108

3/24/06

EASYTRAK 2 Family of Leads

Guidant Corp.

St. Paul, MN

55112

Addition of a second source supplier for the conductor coil used in the device.

P010012/S111

3/31/06

CONTAK CD/ EASYTRAK

Guidant Corp.

St. Paul, MN

55112

Addition of a requirement for the thickness of the gold plating on the accelerometer bond pad for the devices.

P010012/S112

3/31/06

CONTAK RENEWAL Family of CRT-Ds

Guidant Corp.

St. Paul, MN

55112

Adding an inline underfill process in hybrid manufacturing.

P010012/S113

3/31/06

CONTAK CD/ EASYTRAK

Guidant Corp.

St. Paul, MN

55112

Change from a manual to an automated system for inspecting the inner seals present in the device header.

P010012/S114

3/31/06

CONTAK CD/ EASYTRAK

Guidant Corp.

St. Paul, MN

55112

Change to the operator handling/cleaning instructions.

P010012/S115

3/31/06

CONTAK CD/ EASYTRAK

Guidant Corp.

St. Paul, MN

55112

Change from laser etching to laser oxidizing for the marking process for pulse generator cans.

P010031/S036

3/9/06

Marquis, Maximo, InSync, Entrust, and Intrinsic Family of Implantable Cardioverter Defibrillators (ICDs)

Medtronic, Inc.

Shoreview, MN

55126

Addition of an in-process Quality Assurance (QA) test to the Final Functional Testing.

P020009/S024

3/2/06

Express/Express 2 Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Modification of the equipment nozzle to the mold used for making the manifold of the above-stated devices.

P020009/S025

3/3/06

Express/Express 2 Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Changes to the mandrel.

P020022/S004

3/3/06

Bayer VERSANT HCV RNA 3.0 Assay (bDNA)

Bayer Healthcare LLC

East Walpole, MA

02032

Change in packaging and labeling.

P030005/S030

3/31/06

CONTAK RENEWAL TR

Guidant Corp.

St. Paul, MN

55112

Change to the placement requirement for the inner seal for the device.

P030005/S031

3/31/06

CONTAK RENEWAL TR

Guidant Corp.

St. Paul, MN

55112

Addition of a requirement for the thickness of the gold plating on the accelerometer bond pad for the devices.

P030005/S032

3/31/06

CONTAK RENEWAL TR

Guidant Corporation

St. Paul, MN

55112

Change from laser etching to laser oxidizing for the marking process for pulse generator cans.

P030025/S026

3/3/06

Paclitaxel-eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Changes to the mandrel.

P030025/S027

3/29/06

Taxus Express² Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the processing order for pre-loading the stent protector and the addition of an inspection to verify the stent protector outer diameter.

P040012/S004

3/24/06

RX ACCULINK and ACCULINK Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Reducing sampling AQL for strain relief component dimensional inspection.

P040012/S005

3/24/06

RX ACCULINK and ACCULINK Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Changes implemented to the packaging manufacturing process instruction (MPI2027943, Pouch/Header Bag Packaging Procedure). Changes pertain to the manufacturing inspection of pouch/pouch seal.

P040012/S006

3/24/06

RX ACCULINK and ACCULINK Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Removal of the option of using isopropyl alcohol (IPA) and a dry wipe for removing particulates prior to loading the stent on the delivery system.

P040012/S007

3/24/06

RX ACCULINK and ACCULINK Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Use of new tooling to expand the stents during the stent fabrication operation for the OTW and RX ACCULINK Nitinol stents.

P040012/S011

3/24/06

Acculink and RX Acculink Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Change to the distal outer member bonding procedure.

P040012/S012

3/24/06

Acculink and RX Acculink Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Change to modify the visual inspection criteria for the distal bond junction.

P040012/S013

3/24/06

Acculink and RX Acculink Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Change in the procedure for verifying stent outer diameter during stent cleaning process.

P040012/S014

3/24/06

Acculink and RX Acculink Carotid Stent Systems

Guidant Corp., Endovascular Solutions

Santa Clara, CA

95404

Change in the tip bond procedure, deletion of a redundant reinspection and rework process step, and a change in the in-process specification for the tip.

P040016/S008

3/3/06

Liberte Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Changes to the mandrel.

P040043/S009

3/9/06

GORE TAG Thoracic Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff, AZ

86003

Updating the visual standard referenced in the post-crush TAG inspection procedure.