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

FDA Pre-Market Approval

FDA Class 3 ·Mentor Memory Shape Breast Implants

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ACRYLIC IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY DR / VR ICD SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G pump

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse VR DR, Fortify Assura VR DR

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with the ThermaFix

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled

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

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex Low Voltage Passive

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter