- Device
- GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S121
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-01-22
- Decision code
- OK30
- Date received
- 2021-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Computer hardware and software upgrades for bacterial endotoxin testing equipment.