PMA P180001S017

Device: Zenith Fenestrated AAA Endovascular Graft
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S017
Product code: MIH
Decision date: 2026-05-21
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval for a new supplier for a component of delivery systems of the Zenith (Flex) AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, Zenith Alpha & Alpha2 Thoracic Endovascular Graft, Zenith Dissection Endovascular System

Current openFDA PMA Record#

Device: Zenith Fenestrated AAA Endovascular Graft
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S017
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-05-21
Decision code: OK30
Date received: 2026-04-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a new supplier for a component of delivery systems of the Zenith (Flex) AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, Zenith Alpha & Alpha2 Thoracic Endovascular Graft, Zenith Dissection Endovascular System