Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Ellipse, Fortify, Fortify Assura, and Quadra Assura MP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Fortify, Fortify Assura, Ellipse

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path Duo and Therapy Cool Flex

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PENTA LEAD SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE ICD SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS

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

FDA Pre-Market Approval

FDA Class 3 ·TactiFlex Ablation Catheter, Sensor Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF FAMILY OF CRT-D'S

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

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

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA FAMILY OF DEFIBRILLATION LEADS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA EPIC/EPIC SUPRA VALVES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIFY, QUICKSITE, QUICKFLEX,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILIES OF ICD DEVICE