- Device
- GORE® EXCLUDER® AAA Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S208
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-06-23
- Decision code
- OK30
- Date received
- 2026-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a torque bump bond strength requirement to the GORE® EXCLUDER® AAA Endoprosthesis delivery system subassembly specification for SIM-PULL catheters