Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS NEUROSTIMULATION SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS NEUROSTIMULATION (IPG) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS NEUROSTIMULATION (IPG) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENS

Stent, Coronary

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS VALVED CONDUIT; DURAFLEX LOW PRES

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM