PMA P020018S070

Device: Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac Branch
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S070
Product code: MIH
Decision date: 2026-09-17
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval for delivery system manufacturing changes for Zenith Fenestrated AAA Endovascular Graft and Zenith Iliac Branch

Current openFDA PMA Record#

Device: Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac Branch
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S070
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-09-17
Decision code: OK30
Date received: 2026-08-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for delivery system manufacturing changes for Zenith Fenestrated AAA Endovascular Graft and Zenith Iliac Branch