- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S048
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2025-11-24
- Decision code
- APPR
- Date received
- 2025-08-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a reduced profile balloon catheter delivery system and modified packaging for the 10 and 11mm diameter sizes of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis