PMA P180001S016

Device: Zenith Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S016
Product code: MIH
Decision date: 2026-05-08
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: modifications to nitinol processing steps for components of the delivery systems for the Zenith Alpha 2 Thoracic Endovascular Graft and the Zenith Dissection Endovascular System

Current openFDA PMA Record#

Device: Zenith Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S016
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-05-08
Decision code: OK30
Date received: 2026-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modifications to nitinol processing steps for components of the delivery systems for the Zenith Alpha 2 Thoracic Endovascular Graft and the Zenith Dissection Endovascular System