System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS LASER SHEATH (SLS)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter and Manual Retraction Kit

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PreveLeak Surgical Sealant & 10pk applictor tips

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DISCOVISC Ophthalmic Viscosurgical Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis product family

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

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

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

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis product family

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPSEndoprosthesis product family