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.

DeviceZenith Alpha Thoracic Endovascular Graft
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCOOK MEDICAL INCORPORATED
Date Received2020-10-29
Decision Date2021-04-27
PMAP140016
SupplementS002
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address COOK MEDICAL INCORPORATED sandet 6 bjaeverskov 4632

Supplemental Filings

Supplement NumberDateSupplement Type
P140016Original 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 IDPMASupp
10827002353937 P140016 000
10827002353692 P140016 000
10827002353685 P140016 000
10827002353678 P140016 000
10827002353661 P140016 000
10827002353654 P140016 000
10827002353647 P140016 000
10827002353630 P140016 000
10827002353623 P140016 000
10827002353616 P140016 000
10827002353609 P140016 000
10827002353593 P140016 000
10827002353586 P140016 000
10827002353708 P140016 000
10827002353715 P140016 000
10827002353722 P140016 000
10827002353920 P140016 000
10827002353913 P140016 000
10827002353869 P140016 000
10827002353852 P140016 000
10827002353845 P140016 000
10827002353838 P140016 000
10827002353821 P140016 000
10827002353814 P140016 000
10827002353760 P140016 000
10827002353753 P140016 000
10827002353746 P140016 000
10827002353739 P140016 000
10827002353579 P140016 000
10827002353562 P140016 000
10827002353555 P140016 000
10827002353395 P140016 000
10827002353388 P140016 000
10827002353371 P140016 000
10827002353364 P140016 000
10827002353357 P140016 000
10827002353340 P140016 000
10827002353333 P140016 000
10827002353326 P140016 000
10827002353319 P140016 000
10827002353302 P140016 000
10827002353296 P140016 000
10827002353289 P140016 000
10827002353401 P140016 000
10827002353418 P140016 000
10827002353425 P140016 000
10827002353548 P140016 000
10827002353531 P140016 000
10827002353524 P140016 000
10827002353517 P140016 000
10827002353500 P140016 000
10827002353494 P140016 000
10827002353487 P140016 000
10827002353470 P140016 000
10827002353463 P140016 000
10827002353456 P140016 000
10827002353449 P140016 000
10827002353432 P140016 000
10827002353272 P140016 000
10827002353944 P140016 000
10827002382364 P140016 000
10827002380728 P140016 000
10827002380551 P140016 000
10827002380414 P140016 000
10827002380285 P140016 000
10827002380278 P140016 000
10827002380254 P140016 000
10827002380247 P140016 000
10827002380230 P140016 000
10827002363462 P140016 000
10827002355269 P140016 000
10827002355252 P140016 000
10827002355245 P140016 000
10827002380759 P140016 000
10827002381718 P140016 000
10827002381725 P140016 000
10827002382203 P140016 000
10827002382166 P140016 000
10827002382081 P140016 000
10827002382043 P140016 000
10827002382036 P140016 000
10827002382012 P140016 000
10827002381916 P140016 000
10827002381909 P140016 000
10827002381800 P140016 000
10827002381794 P140016 000
10827002381787 P140016 000
10827002381732 P140016 000
10827002355238 P140016 000
10827002355221 P140016 000
10827002355214 P140016 000
10827002355047 P140016 000
10827002355030 P140016 000
10827002355023 P140016 000
10827002354040 P140016 000
10827002354033 P140016 000
10827002354026 P140016 000
10827002354019 P140016 000
10827002354002 P140016 000
10827002353999 P140016 000
10827002353982 P140016 000
10827002353975 P140016 000
10827002353968 P140016 000
10827002355054 P140016 000
10827002355061 P140016 000
10827002355078 P140016 000
10827002355207 P140016 000
10827002355191 P140016 000
10827002355184 P140016 000
10827002355177 P140016 000
10827002355160 P140016 000
10827002355153 P140016 000
10827002355146 P140016 000
10827002355139 P140016 000
10827002355122 P140016 000
10827002355115 P140016 000
10827002355108 P140016 000
10827002355092 P140016 000
10827002353951 P140016 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.