- Device
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P230023
- Supplement
- S009
- Product code
- QZK
- Generic name
- Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
- Decision date
- 2025-09-09
- Decision code
- OK30
- Date received
- 2025-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an additional primary supplier of radiopaque markers used in the GORE® EXCLUDER® Iliac Branch Endoprosthesis, Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, and GORE® TAG® Thoracic Branch Endoprosthesis