Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R)

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM CRT-D 1711/1741

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II ™ Cooled Ablation Catheter and Cable

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire IV IPG

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn Endoprosthesis

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG,

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE® Transcarotid Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. RADIANZ Vascular Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse DR, Ellipse VR

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphereTM Y-90 Glass Microspheres System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE® Family of Injectable Gels