Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ)

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

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

FDA Pre-Market Approval

FDA Class 3 ·SJM QUADRA ASSURA AND UNIFY ASSURA CRTDS

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters Series Mechanical Heart Valve, 15mm HP

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTER HP VALVED GRAFT WITH GELWEAVE VALSALVA

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·SJM Infinity Deep Brain Stimulation (DBS) Neurostimulation System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters Valved Graft with Hemashield graft technology

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters Series Mechanical Heart Valve, 15mm HP

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc lgM assay and Control

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM TEST SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT