Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·EXCLUDER BIFURCATED AAA ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS Vascular Stent

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROTHESIS

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

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·BARD E-LUMINEXX VASCULAR STENT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

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

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

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

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·FREEDOM DRIVER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

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

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE