PMA P210032S024
- Device
- GORE® TAG® Thoracic Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P210032
- Supplement
- S024
- Product code
- MIH
- Decision date
- 2025-10-17
- Classification
- Cardiovascular
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- implementation of an additional supplier of a raw material of the CBAS Heparin Surface
Current openFDA PMA Record#
- Device
- GORE® TAG® Thoracic Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P210032
- Supplement
- S024
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2025-10-17
- Decision code
- OK30
- Date received
- 2025-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an additional supplier of a raw material of the CBAS Heparin Surface