- Device
- GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S207
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-07-08
- Decision code
- APPR
- Date received
- 2026-04-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification to the 2nd deployment fiber used in the delivery system for the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis, and GORE® EXCLUDER® Iliac Branch Endoprosthesis devices