Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G Insulin Pump

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G Insulin Pump

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

FDA Pre-Market Approval

FDA Class 3 ·Quickflex u and Quartet CRT Leads

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI, MRI Activator, and Tendril MRI

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INTUITY Elite Valve System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN RT

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY PACEMAKERS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT CATHETERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·J-LOOP POST.CHAM. IOL

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENOUS DEFIBRILLATION LEAD

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS