Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Express® LD Iliac Premounted Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus-

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Self-Expanding Stent System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR SYSTEM (S-ICD)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE TRANSCAROTID STENT SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·S-ICD SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Lotus Edge Valve System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control