Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA INJECTABLE GEL

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprothesis

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Guardian Link (3) Transmitter (MiniMed 670G System)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN SALINE-FILLED BREAST IMPLANTS

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSORS

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9

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

FDA Pre-Market Approval

FDA Class 3 ·ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES