Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD DVPB3D4 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1 Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4 Cobalt XT MR

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta Heart Valves

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Fix Novus Lead (4076, 5076)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Low Porosity Valved Conduit

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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-Piece Acrylic Monofocal

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·Liposorber LA-15 System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Solara Bipolar CRT-P, Solara Q

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix