Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM

Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

FDA Pre-Market Approval

FDA Class 3 ·eCoin implanted tibial stimulator

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX EXCIMER LASER SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·SECURE-C ARTIFICIAL CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NUVASIVE PCM CERVICAL DISC SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cross-Seal Suture-Mediated Vascular Closure Device System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSORS

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)