Zenith Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P180001 S001

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

Approval of the charter for the surveillance project referenced above

• Device: Zenith Dissection Endovascular System
• Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: WILLIAM COOK EUROPE APS
• Date Received: 2019-10-01
• Decision Date: 2019-10-31
• PMA: P180001
• Supplement: S001
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• 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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10827002474380	P180001	000
10827002474397	P180001	000
10827002474403	P180001	000
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10827002474434	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
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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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10827002474793	P180001	000
10827002474960	P180001	000