- Device
- Gore TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S120
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-15
- Decision code
- APPR
- Date received
- 2020-09-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for implementation of updates to the Instructions for Use (IFU).