PMA P180001S004

Device: Zenith Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S004
Product code: MIH
Decision date: 2022-04-14
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for an additional seal on one side of the Zenith Dissection Endovascular Graft primary packaging and new specifications for the position of an already applied seal on the opposite side.

Current openFDA PMA Record#

Device: Zenith Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S004
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-04-14
Decision code: APPR
Date received: 2022-03-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional seal on one side of the Zenith Dissection Endovascular Graft primary packaging and new specifications for the position of an already applied seal on the opposite side.