ZENITH TX2 TAA ENDOVASCULAR GRAFT

FDA Premarket Approval P070016 S010

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

Change to the coating process parameters for the release-wires.

DeviceZENITH TX2 TAA ENDOVASCULAR GRAFT
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantWILLIAM COOK EUROPE APS
Date Received2015-07-06
Decision Date2015-08-03
PMAP070016
SupplementS010
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov 

Supplemental Filings

Supplement NumberDateSupplement Type
P070016Original Filing
S010 2015-07-06 30-day Notice
S009 2014-11-03 Real-time Process
S008
S007 2013-04-23 Special (immediate Track)
S006 2011-07-19 Normal 180 Day Track No User Fee
S005 2011-07-12 135 Review Track For 30-day Notice
S004 2009-04-06 Normal 180 Day Track
S003 2008-09-05 135 Review Track For 30-day Notice
S002 2008-08-15 Normal 180 Day Track
S001 2008-06-02 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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10827002534879 P070016 001

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