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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P FAMILY OF DEVICES (FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE/SJM MASTERS SERIES & SJM REGENT HEART VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters HP Valved Graft

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR/BIOCOR SUPRA VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MODEL CAVG-304 PROTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR AND EPIC VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MODEL CAVG-404 PROTHESIS

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 ·The Tendril MRI lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM ELLIPSE AND FORTIFY ASSURA ICDS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON CTM IPG NEUROSTIMULATION SYSTEM

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, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR VALVE & SUPRA VALVE

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM IMPLANTABLE ICDS & CRT-DS

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 ·REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES