PMA P180001S005

Device: Zenith Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S005
Product code: MIH
Decision date: 2022-06-02
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for updating the Instructions for Use to report the theoretical (i.e., calculated) maximum length for the Zenith Dissection Endovascular Stent.

Current openFDA PMA Record#

Device: Zenith Dissection Endovascular System
Applicant: William Cook Europe Aps
PMA number: P180001
Supplement: S005
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-06-02
Decision code: APPR
Date received: 2022-05-05
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updating the Instructions for Use to report the theoretical (i.e., calculated) maximum length for the Zenith Dissection Endovascular Stent.