PMA P200030S023

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Applicant: W. L. Gore and Associates, Inc.
PMA number: P200030
Supplement: S023
Product code: MIH
Decision date: 2025-12-05
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for modification of the primary sewn tubular sleeve manufacturing process, a change to the primary sleeve attachment fiber, and a change to the proximal primary sleeve attachment pattern for the GORE® EXCLUDER® Conformable AAA Endoprosthesis.

Current openFDA PMA Record#

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Applicant: W. L. Gore and Associates, Inc.
PMA number: P200030
Supplement: S023
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2025-12-05
Decision code: APPR
Date received: 2025-09-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modification of the primary sewn tubular sleeve manufacturing process, a change to the primary sleeve attachment fiber, and a change to the proximal primary sleeve attachment pattern for the GORE® EXCLUDER® Conformable AAA Endoprosthesis.