Zenith Alpha Thoracic Endovascular Graft

FDA Premarket Approval P140016 S003

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

A change to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires

DeviceZenith Alpha Thoracic Endovascular Graft
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCOOK MEDICAL INCORPORATED
Date Received2021-06-11
Decision Date2021-07-09
PMAP140016
SupplementS003
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COOK MEDICAL INCORPORATED sandet 6 bjaeverskov 4632

Supplemental Filings

Supplement NumberDateSupplement Type
P140016Original Filing
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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