Zenith Dissection Endovascular System

FDA Premarket Approval P180001 S006

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 NumberS006 Date Received06/06/2022 Decision Date09/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-06-06
Decision Date2022-09-01
PMAP180001
SupplementS006
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressWILLIAM COOK EUROPE APS
sandet 6, Dk-4632
bjaeverskov  PMA NumberP180001 Supplement NumberS006 Date Received06/06/2022 Decision Date09/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For A Design Change To The Introduction System Green Release Knob Of The Cook Zenith Dissection Endovascular System.

Supplemental Filings

Supplement NumberDateSupplement Type
P180001Original Filing
S006 2022-06-06 Real-time Process
S005 2022-05-05 Special (immediate Track)
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

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