Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·LUMBAR I/F CAGE SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE II/FINELINE II STEROX PACING LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RX5000 PROGRAMMER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALL STENT ILIAC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HYDROVIEW IOL BLANK MATERIAL