- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S045
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- 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