Zenith Dissection Endovascular System

FDA Premarket Approval P180001 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

Premarket approval application supplement, which requested approval of the labeling updates for the post-approval study (pas) has been approved.

DeviceZenith Dissection Endovascular System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantWILLIAM COOK EUROPE APS
Date Received2020-10-02
Decision Date2021-03-31
PMAP180001
SupplementS002
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov 

Supplemental Filings

Supplement NumberDateSupplement Type
P180001Original Filing
S002 2020-10-02 Normal 180 Day Track No User Fee
S001 2019-10-01 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
10827002474366 P180001 000
10827002474526 P180001 000
10827002474533 P180001 000
10827002474540 P180001 000
10827002474557 P180001 000
10827002474564 P180001 000
10827002474571 P180001 000
10827002474588 P180001 000
10827002474595 P180001 000
10827002474601 P180001 000
10827002474618 P180001 000
10827002474625 P180001 000
10827002474632 P180001 000
10827002474649 P180001 000
10827002474519 P180001 000
10827002474502 P180001 000
10827002474373 P180001 000
10827002474380 P180001 000
10827002474397 P180001 000
10827002474403 P180001 000
10827002474410 P180001 000
10827002474427 P180001 000
10827002474434 P180001 000
10827002474441 P180001 000
10827002474458 P180001 000
10827002474465 P180001 000
10827002474472 P180001 000
10827002474489 P180001 000
10827002474496 P180001 000
10827002474656 P180001 000
10827002474663 P180001 000
10827002474823 P180001 000
10827002474830 P180001 000
10827002474847 P180001 000
10827002474854 P180001 000
10827002474861 P180001 000
10827002474878 P180001 000
10827002474885 P180001 000
10827002474892 P180001 000
10827002474915 P180001 000
10827002474922 P180001 000
10827002474939 P180001 000
10827002474946 P180001 000
10827002474953 P180001 000
10827002474816 P180001 000
10827002474809 P180001 000
10827002474670 P180001 000
10827002474687 P180001 000
10827002474694 P180001 000
10827002474700 P180001 000
10827002474717 P180001 000
10827002474724 P180001 000
10827002474731 P180001 000
10827002474748 P180001 000
10827002474755 P180001 000
10827002474762 P180001 000
10827002474779 P180001 000
10827002474786 P180001 000
10827002474793 P180001 000
10827002474960 P180001 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.