PMA P040043S137

Device: Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S137
Product code: MIH
Decision date: 2024-11-18
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval for revisions to the instructions for use to add the results of the Collaborative TEVAR Surveillance Project

Current openFDA PMA Record#

Device: Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S137
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2024-11-18
Decision code: APPR
Date received: 2024-05-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for revisions to the instructions for use to add the results of the Collaborative TEVAR Surveillance Project