Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ALGOVITA SPINAL CORD STIMULATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR 3PC & 1PC MONOFOCAL; TECNIS 1PC MONOFOCAL, 1PC MULTIFOCAL AND 1PC TORIC MONOFOCAL, 1PC OPTIBULE & 3PC OPTIBLUE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3PC MULTIFOCAL

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·REZOOM 3-PC MULTIFOCAL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TENIS 3-PC MONOFOCAL-ZA9003

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus UBT System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® Foldable Acrylic IOL with OptiEdge, Model ZA9003

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® Multifocal 3-Piece IOL, Model ZMA00

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR® Soft Acrylic Posterior Chamber IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Philips Laser System

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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