Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM™ S-ICD Model A209; EMBLEM™ MRI S-ICD Model A219

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

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent with Delivery System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT VENOUS ENDOPROSTHESIS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Automated Screening Tool

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent Venous Endoprosthesis with Unistep Plus Delivery System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (VENOUS) ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE TRANSCAROTID STENT SYSTEM

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent System