Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL LEAD

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval

FDA Class 3 ·MELAFIND

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVELS)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR-CORONARY STENT ON RX SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERMAX CERAMIC TOTAL HIP SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·RESURE SEALANT