- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S043
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2024-04-02
- Decision code
- APPR
- Date received
- 2024-03-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update to reflect the use of GORE VIABAHN VBX Balloon Expandable Endoprosthesis with thoracoabdominal and pararenal branched devices that are indicated with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component