System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody

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

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis

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 COMPANION 2 DRIVER SYSTEM

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

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 ENDOPROSTHESIS

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

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER