- Device
- GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S186
- 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 new manufacturing line for the GORE EXCLUDER AAA Endoprosthesis and GORE EXCLUDER Iliac Branch Endoprosthesis.