Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR, 2 PORT HEADER

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·BRIO NEUROSTIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prodigy Leads and Extension Insertion Tool

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Lead and Extension Insertion Tool

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·TRIFECA HEART VALVE

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 ·EPIC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SJM DURATA, RIATA ST OPTIM & RIATA ST FAMILIES OF DEFIBRILLATION LEADS