Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY(R) CARDIAC PACING SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Setrox S, Solia S, Safio S

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) THERA(TM) PULSE GENERATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·R5.111WE(REVISION OF R5.85WE)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META II MODEL 1204H CARDIAC PACING SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333