- Device
- Gore Excluder Conformable AAA Endoprosthesis (EXCC)
- Applicant
- W. L. Gore and Associates, Inc.
- PMA number
- P200030
- Supplement
- S006
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-12-16
- Decision code
- OK30
- Date received
- 2021-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a manufacturing line for the Graft Attach and Stent Graft Crush manufacturing process for the GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) device.