Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervical Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·SECURE-C ARTIFICIAL CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NUVASIVE PCM CERVICAL DISC SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

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

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)