Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Lead

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM AND EMBLEM MRI S-ICD SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App

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

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation 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)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE TRANSCAROTID STENT SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD VI Electrode (Lead)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter