PMA P210032S025

Device: GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P210032
Supplement: S025
Product code: MIH
Decision date: 2026-03-09
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: changes to the manufacturing inspection sampling plan for GORE® TAG® Thoracic Endoprosthesis, the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, and GORE® TAG® Thoracic Branch Endoprosthesis

Current openFDA PMA Record#

Device: GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P210032
Supplement: S025
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-03-09
Decision code: OK30
Date received: 2026-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the manufacturing inspection sampling plan for GORE® TAG® Thoracic Endoprosthesis, the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, and GORE® TAG® Thoracic Branch Endoprosthesis