Zenith Dissection Endovascular System

FDA Premarket Approval P180001 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Premarket approval application supplement, which requested approval of the labeling updates for the post-approval study (pas) has been approved.

• Device: Zenith Dissection Endovascular System
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: WILLIAM COOK EUROPE APS
• Date Received: 2020-10-02
• Decision Date: 2021-03-31
• PMA: P180001
• Supplement: S002
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Pas
• Expedited Review: No
• Combination Product: No
• Applicant Address: WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov

Supplemental Filings

Supplement Number	Date	Supplement Type
P180001		Original Filing
S006	2022-06-06	Real-time Process
S005	2022-05-05	Special (immediate Track)
S004	2022-03-18	Special (immediate Track)
S003	2021-11-15	30-day Notice
S002	2020-10-02	Normal 180 Day Track No User Fee
S001	2019-10-01	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
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10827002474526	P180001	000
10827002474533	P180001	000
10827002474540	P180001	000
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10827002474595	P180001	000
10827002474601	P180001	000
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10827002474380	P180001	000
10827002474397	P180001	000
10827002474403	P180001	000
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10827002474656	P180001	000
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10827002474823	P180001	000
10827002474830	P180001	000
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10827002474861	P180001	000
10827002474878	P180001	000
10827002474885	P180001	000
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10827002474915	P180001	000
10827002474922	P180001	000
10827002474939	P180001	000
10827002474946	P180001	000
10827002474953	P180001	000
10827002474816	P180001	000
10827002474809	P180001	000
10827002474670	P180001	000
10827002474687	P180001	000
10827002474694	P180001	000
10827002474700	P180001	000
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10827002474960	P180001	000