Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Patient Management System, LATITUDE™ Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NXT Syst

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·RELAY/DASH/STRIDE/DART PACING SYSTEMS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE (MODEL U125), VALITUDE X4 (MODEL U128) CRT-PS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·BIOCOR, EPIC AND EPIC SUPRA VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM & VITALITY FAMILIES OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD CAP ACCESSORY KIT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters HP Valved Graft

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK AND ACUITY SPIRAL LEAD SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Valve Implantation (TAVI) System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 Drug Collar Component Dwell Time

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Muscular VSD Occluder

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II & BLAZER PRIME HTD CATHETERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ClearView™ 3

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™ Plus Tissue Heart Valves, Epic™ Max Tissue Heart Valves, Epic™ Tissue Heart Valves

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MECHANICAL HEART VALVE SJM(R) MASTER SERIES