PMA P040043S129
- Device
- GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- PMA number
- P040043
- Supplement
- S129
- Product code
- MIH
- Decision date
- 2021-06-16
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Approval order statement
- Additional Stent Graft Manufacturing Equipment To Expand Production Capacity
Current openFDA PMA Record
- Device
- GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S129
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-06-16
- Decision code
- OK30
- Date received
- 2021-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional stent graft manufacturing equipment to expand production capacity.