VACUUM BAKE CYCLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ULTRA SOFTWARE MODULE: MODEL 2016

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA 2, ASTRA 3, 4 & 6

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·COREVALVE EVOLUT BIOPROSTHESIS, CORE VALVE BIOPROSTHESIS, ACCUTRAK DELIVERY CATHETER SYSTEM, GEN 3 & GEN4 COMPRESSION LO

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

FDA Pre-Market Approval

FDA Class 3 ·CONCENTRO II CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO II ICD DR/VR

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE 1000A IP LVAS

HEART SYNC, MODELS C-100 AND T-100

FDA 510(k)

FDA Class 3 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX, MINIX ST, NEW IC: L74

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T4 AND T6

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS