Zenith Alpha Thoracic Endovascular Graft

FDA Premarket Approval P140016 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

Approval for labeling update which incorporates the final 5-year results from the post-approval study for continued follow-up of pivotal and continued access patients enrolled in the premarket study.

• Device: Zenith Alpha Thoracic Endovascular Graft
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: COOK MEDICAL INCORPORATED
• Date Received: 2020-10-29
• Decision Date: 2021-04-27
• PMA: P140016
• 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: COOK MEDICAL INCORPORATED sandet 6 bjaeverskov 4632

Supplemental Filings

Supplement Number	Date	Supplement Type
P140016		Original Filing
S005	2022-03-18	Special (immediate Track)
S004	2021-12-03	Special (immediate Track)
S003	2021-06-11	30-day Notice
S002	2020-10-29	Normal 180 Day Track No User Fee
S001	2017-06-28	Special (immediate Track)

NIH GUDID Devices

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