Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PREVAIL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC III CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER/ICD PROGRAMMER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR & SR IPG PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILY OF ICDS

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

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST.JUDE MEDICAL MECHANICAL HEART VALVE, SJM MASTER SERIES MECHANICAL HEART VALVESJM REGENT MECHANICAL HEART VALVE,