Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP AND MITRACLIP NT CLIP DELIVERY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI Lead and INGEVITY non-MRI Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AND VITALITY 2

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN IMPLANTABLE CARDIAC DEFIBRILLATORS

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

FDA Pre-Market Approval

FDA Class 3 ·COGNIS, PROGENY CRT-D AND NG CRT-D MODELS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices: ADVANTIO, INEGNIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav XP and IntellaNav MiFi XP ablation catheters

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER SEPTAL OCCLUDER/AMPLATZER CRIBRIFORM OCCLUDER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Biocor and Epic Heart Valves

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3

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

FDA Pre-Market Approval

FDA Class 3 ·Invive, Intua, Visionist, Valitude

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR IS-1 FAMILY

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

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

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE , VALITUDE X4 CRT-PS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillators (ICDs)

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Muscular VSD Occluder