Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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)

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS ICD DEVICES: EMBLEM.

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System (Urinary)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD - Subcutaneous Devices

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY™ MEGATRON Everolimus-Eluting Platinum Chromi

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Orbera® Intragastric Balloon (IGB) System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Emblem S-ICD System Model A209 / Emblem MRI S-ICD System Model A219

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

Stent, Central Venous

FDA Pre-Market Approval

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