Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional)

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHOTON MICRO MODEL V-194, V-232 AND ATLAS MODEL V-199 , V-240 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV MIFI XP; INTELLATIP MIFI XP

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/INSYNC SENTRY/INSYNC MAXIMO

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® CR2 defibrillator

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK ENCORE 29901 PROGRAMMER

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035