Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 325 PACEMAKER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CHECKMATE(TM) SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CORDIS EXOSEAL VASCULAR CLOSURE DEVICE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART AND SMART CONTROL NITINOL STENT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX ACE VASCULAR CLOSURE DEVICE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SMART CONTROL NITINOL STENT SYSTEMS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART AND SMART CONTROL NITINOL STENT SYSTEM

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)