Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL CATHETER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System,

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·J LOOP POSTERIOR CHAMBER TYPE II 0 & 10

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY DC + PULSE GENERATOR, MODEL 2318L

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL MINI SINUS IMPLANT, 6011

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CARBON TIPPED LEAD ALT.PROD.TRAYS

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AQUASEPT II

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC10 & PC21

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM