Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICD'S

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System (LVAS)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY MODEL 2020T PULSE GENERATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CM(TM) LENSES MODEL 820A

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Dual-8, Therapy 8mm Thermistor, Safire TX Ablation Catheter

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus™ Bioprosthesis, Avalus Ultra™ Bioprosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Crimper 9600CR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT