PMA P200030

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Applicant: W. L. Gore and Associates, Inc.
PMA number: P200030
Supplement: S010
Product code: MIH
Decision date: 2026-07-29
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: removal of UV adhesive application onto the guidewire extension tube via the hypotube assembly during manufacturing of 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: S026
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-07-29
Decision code: OK30
Date received: 2026-07-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of UV adhesive application onto the guidewire extension tube via the hypotube assembly during manufacturing of the GORE® EXCLUDER® Conformable AAA Endoprosthesis