Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL 5000

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS CL Foldable Silicone Intraocular Lens

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris®

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS CL Foldable Silicone Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CT LUCIA Intraocular Lens (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens