- Device
- GORE® TAG® Conformable Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S149
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-03-09
- Decision code
- OK30
- Date received
- 2026-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the manufacturing inspection sampling plan for GORE® TAG® Thoracic Endoprosthesis, the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, and GORE® TAG® Thoracic Branch Endoprosthesis