Zenith Alpha Thoracic Endovascular Graft

FDA Premarket Approval P140016 S005

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

• Device: Zenith Alpha Thoracic Endovascular Graft
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: COOK MEDICAL INCORPORATEDsandet 6bjaeverskov 4632 PMA NumberP140016 Supplement NumberS005 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Date Received: 2022-03-18
• Decision Date: 2022-04-14
• PMA: P140016
• Supplement: S005
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Special (immediate Track)
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: COOK MEDICAL INCORPORATED; sandet 6; bjaeverskov 4632 PMA NumberP140016 Supplement NumberS005 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement ; an Additional Seal On One Side Of The Zenith Alpha Thoracic Endovascular Graft Primary Packaging And New Specifications For The Position Of An Already Applied Seal On The Opposite Side

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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