Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·POLYSAFE(TM) A-TRACK(TM) MODEL AT-332 ENDOCARDIAL

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE AND PRECISE RX NITINOL STENT SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO SERIES 500 P.G. MODELS 501, 505, 509

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·NOVATION CERAMIC ARTICULATION HIP SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·5F & 6/7F MYNX VASCULAR CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon) Brand Contact Lenses

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES CLEAR/VISIBILITY TINTED WITH UV BLOCKER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) SAVVI(TM) SERIES 305 VDD PACING SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON® (senofilcon A) Brand Contact Lenses

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SMART AND SMART CONTROL VASCULAR STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. RADIANZ™ Vascular Stent System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO SERIES 500 P.G. MODELS 501, 505, 509