- Device
- GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S104
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2024-06-27
- Decision code
- OK30
- Date received
- 2024-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of a processing aid and use of an alternate animal tissue source for raw material inputs for the drug substance manufacturing process