PMA P040043S132
- Device
- GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS132 Date Received12/15/2022 Decision Date01/12/2023 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
- PMA number
- P040043
- Supplement
- S132
- Product code
- MIH
- Decision date
- 2023-01-12
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
Current openFDA PMA Record
- Device
- GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S132
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2023-01-12
- Decision code
- APPR
- Date received
- 2022-12-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for implementation of updates to the warnings and MR compatibility information in the Instructions for Use (IFU) and patient implant card.