Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Hyaluronate Gel Implants

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, Deflectable Diagnostic/Ablation Catheter, Celsius Catheter,

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

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

FDA Pre-Market Approval

FDA Class 3 ·RMT THERMOCOOL, NAVISTAR™, NAVISTAR™RMT, NAVISTAR™THERMOCOOL

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ Photodynamic D-Light C PDD System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, To

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·In.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE ICDS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva® Endometrial Ablation System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus™ Deep Brain Stimulation (DBS) System

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LI61AO LENS

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)