Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY XL DR MODEL 5376 PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY SR MODEL 5172 PULSE GENERATOR

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY PULSE GENERATOR MODEL DR 5370

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY PACEMAKERS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE PUMP

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Femoral Introducer Sheath and Hemostasis(FISH) Device

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES