Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENEWAL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous ICD Device (S-ICD): EMBLEM, EMBLEM MRI

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta™ Valve with Glide Technology™

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE COMMUNICATOR

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

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO 3000 CARDIAC ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY FAMILY OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Biocor, Biocor Supra, Epic, Epic Supra

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 ICDS, ORIGEN, INOGEN, DYNAGEN EL; NG2.5 ICDS -ORIGEN, INOGEN, DYNAGEN MINI ICDS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q/RES-Q MICRON

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE Programming System

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaTip MiFi Open Irrigated

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 Delivery System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV DDD/AV II DDDD

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE