Zenith Alpha Thoracic Endovascular Graft

FDA Premarket Approval P140016 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 to remove blunt thoracic aortic injury from the indications for use and remove references to the smaller diameter grafts that have been removed from the market.

• Device: Zenith Alpha Thoracic Endovascular Graft
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: COOK MEDICAL INCORPORATED
• Date Received: 2017-06-28
• Decision Date: 2017-07-28
• PMA: P140016
• Supplement: S001
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489
• Labeling: Labeling Labeling Part 2

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

Device ID	PMA	Supp
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