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

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, Serena Quadripolar CRT-P, Sola

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator {SCS) Systems

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System