PMA P020018S066

Device: Zenith Flex AAA Endovascular System and Zenith Iliac Branch
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S066
Product code: MIH
Decision date: 2026-03-09
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: changes to the materials used to manufacture the suture for the Zenith Flex AAA Endovascular System and Zenith Iliac Branch

Current openFDA PMA Record#

Device: Zenith Flex AAA Endovascular System and Zenith Iliac Branch
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S066
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-03-09
Decision code: OK30
Date received: 2026-02-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the materials used to manufacture the suture for the Zenith Flex AAA Endovascular System and Zenith Iliac Branch