Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (TIPS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DIVA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

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

FDA Pre-Market Approval

CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES

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