- Device
- GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S088
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2021-12-03
- Decision code
- OK30
- Date received
- 2021-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of manufacturing of the graft tube component and related Quality control activities from the Medical West facility to the Woody Springs facility.