PMA P040043S147

Device: GORE® TAG® Conformable Thoracic Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S147
Product code: MIH
Decision date: 2025-10-15
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: addition of a new supplier of the leading olive component for the GORE TAG Conformable Thoracic Endoprosthesis delivery system

Current openFDA PMA Record#

Device: GORE® TAG® Conformable Thoracic Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S147
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2025-10-15
Decision code: OK30
Date received: 2025-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new supplier of the leading olive component for the GORE TAG Conformable Thoracic Endoprosthesis delivery system