Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 333 PACEMAKER SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLOON-EXPANDABLE STENT

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus Urea Breath Test System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM

Stent, Iliac

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SBL-3 Intraocular Lens

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY

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