PMA P130006

Device: GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P130006
Supplement: S094
Product code: PFV
Decision date: 2025-10-17
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement: implementation of an additional supplier of a raw material of the CBAS Heparin Surface

Current openFDA PMA Record#

Device: GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P130006
Supplement: S110
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2025-10-17
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an additional supplier of a raw material of the CBAS Heparin Surface