Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·DARDIK BIOGRAFT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·RELAY-DASH PACING SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM SUBCUTANEOUS ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·BIOCOR/EPIC VALVE

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE FAMILIES OF PACING LEADS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROX

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK, BIPOLAR ENDOCARDIAL

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO 3000 TM CARDIAC ABLATION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI Models L110, L111, L131;

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Contak Renewal