Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TACHY ADAPTER (ACCESSORY)

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED ™ Absorbable Adhesion Barrier

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve TM EvolutTM R Transcatheter Aortic Valve, Medtronic CoreValveTM EvolutTM PRO Transcatheter Aortic V

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TEMPO AND META PULSE GENERATORS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta; Percepta Bipolar, Quadripolar; Serena Bipolar, Quadripolar; Syncra; Viva CRT-P

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore and Itrel Spinal Cord Stimulation Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Nevro Corp Senza Spinal Cord Stimulation System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Temperature Ablation Catheter

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn VBX Balloon Expandable Endoprosthesis

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade MRI Pacemakers

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Wolverine Coronary Cutting Balloon

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova™ Self-Expanding Stent System