- Device
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P230023
- Supplement
- S011
- Product code
- QZK
- Generic name
- Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
- Decision date
- 2026-04-09
- Decision code
- OK30
- Date received
- 2026-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an alternative UV curing system for assembly of components of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) delivery system