PMA P020018S067

Device: Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith Flex with Spi
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S067
Product code: MIH
Decision date: 2026-04-21
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: changes to the manufacturing process of the gold marker bands used in the Zenith Flex AAA, Zenith Renu, Spiral-Z Iliac Leg, and Zenith Iliac Branch stent graft systems

Current openFDA PMA Record#

Device: Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith Flex with Spi
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S067
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-04-21
Decision code: OK30
Date received: 2026-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the manufacturing process of the gold marker bands used in the Zenith Flex AAA, Zenith Renu, Spiral-Z Iliac Leg, and Zenith Iliac Branch stent graft systems