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

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Conformable AAA Endoprosthesis

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) Assay

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

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

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·EXCLUDER AAA ENDOPROSTHESIS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·E-LUMINEXX VASCULAR STENT

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HS System

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

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis product family

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·TMR2000 HOLMIUM LASER SYSTEM