Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF SENSOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY VR DF-4 FAMILY OF ICDS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS/ISOFLEX S/P/OPTIM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC/EPIC II HF & ATLAS + HF CRT-D'S

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hanock II Bioprosthesis, Models T505 and T510

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MINILINK REAL-TIME TRANSMITTER (MMT-7703)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDD MODEL 1230 PACER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CARELINK IPRO THERAPY MANAGEMENT SOFTWARE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE IOLS

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx