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

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

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·QUICKFLEX U AND QUARTET LEADS (CRT)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassy Systems

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers.

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag™ Circulatory Support System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG (R) ULTILOG (TM) MODELS 2040K,2040T