PMA P210032S026

Device: GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1
Applicant: W. L. Gore & Associates, Inc.
PMA number: P210032
Supplement: S026
Product code: MIH
Decision date: 2026-07-13
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P210032/S015.

Current openFDA PMA Record#

Device: GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1
Applicant: W. L. Gore & Associates, Inc.
PMA number: P210032
Supplement: S026
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-07-13
Decision code: APPR
Date received: 2026-06-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P210032/S015.