Zenith Dissection Endovascular System

FDA Premarket Approval P180001 S004

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

DeviceZenith Dissection Endovascular System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantWILLIAM COOK EUROPE APSsandet 6, Dk-4632bjaeverskov  PMA NumberP180001 Supplement NumberS004 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 Received2022-03-18
Decision Date2022-04-14
PMAP180001
SupplementS004
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressWILLIAM COOK EUROPE APS
sandet 6, Dk-4632
bjaeverskov  PMA NumberP180001 Supplement NumberS004 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 Dissection Endovascular Graft Primary Packaging And New Specifications For The Position Of An Already Applied Seal On The Opposite Side

Supplemental Filings

Supplement NumberDateSupplement Type
P180001Original Filing
S004 2022-03-18 Special (immediate Track)
S003 2021-11-15 30-day Notice
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
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