Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS O

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify Cervical Artificial Disc

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AF-1 Family of Intraocular Lens (IOL)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity RX and OTW Zotarolimus-Eluting Coronary Stent System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Navistar RMT Thermocool Catheter

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure Quadra, and Quadra Allure MP

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM