Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (22MM)

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II (HMII) Left Ventricular Assist System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device