PMA P200030S025

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Applicant: W. L. Gore and Associates, Inc.
PMA number: P200030
Supplement: S025
Product code: MIH
Decision date: 2026-07-08
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for modification to the 2nd deployment fiber used in the delivery system for the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis, and GORE® EXCLUDER® Iliac Branch Endoprosthesis devices

Current openFDA PMA Record#

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Applicant: W. L. Gore and Associates, Inc.
PMA number: P200030
Supplement: S025
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-07-08
Decision code: APPR
Date received: 2026-04-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modification to the 2nd deployment fiber used in the delivery system for the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis, and GORE® EXCLUDER® Iliac Branch Endoprosthesis devices