- Device
- GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
- Applicant
- W. L. Gore and Associates, Inc.
- PMA number
- P200030
- Supplement
- S008
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-07-27
- Decision code
- OK30
- Date received
- 2022-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an update to the burst strength destructive testing sampling plan for the GORE EXCLUDER Conformable AAA Endoprosthesis.