Zenith AAA Endovascular Graft

FDA Premarket Approval P020018 S059

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 the use of a stent orientation tool in the manufacturing of the zenith aaa endovascular graft

DeviceZenith AAA Endovascular Graft
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCOOK, INC.
Date Received2020-09-17
Decision Date2020-10-08
PMAP020018
SupplementS059
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COOK, INC. 750 Daniels Way p.o. Box 489 bloomington, IN 47402

Supplemental Filings

Supplement NumberDateSupplement Type
P020018Original Filing
S059 2020-09-17 Special (immediate Track)
S058 2018-06-22 Special (immediate Track)
S057 2016-11-09 Special (immediate Track)
S056 2016-05-04 Special (immediate Track)
S055 2014-11-03 Real-time Process
S054
S053 2014-09-22 30-day Notice
S052 2014-05-06 Special (immediate Track)
S051
S050 2014-02-11 Normal 180 Day Track No User Fee
S049 2013-03-26 Special (immediate Track)
S048 2013-03-18 Normal 180 Day Track No User Fee
S047 2012-11-13 30-day Notice
S046 2012-07-26 Normal 180 Day Track
S045 2012-06-28 Special (immediate Track)
S044 2012-05-04 Normal 180 Day Track No User Fee
S043 2012-05-04 Normal 180 Day Track No User Fee
S042 2012-01-10 Normal 180 Day Track
S041 2011-10-11 Normal 180 Day Track
S040 2011-10-07 Panel Track
S039 2011-06-23 Normal 180 Day Track No User Fee
S038 2011-05-03 30-day Notice
S037 2010-08-30 Normal 180 Day Track
S036 2010-06-18 30-day Notice
S035
S034 2010-03-10 Special (immediate Track)
S033 2009-06-04 Real-time Process
S032 2009-02-23 Normal 180 Day Track
S031 2009-02-02 Special (immediate Track)
S030 2008-11-24 30-day Notice
S029 2008-08-15 135 Review Track For 30-day Notice
S028
S027 2008-05-09 Special (immediate Track)
S026 2008-03-03 Normal 180 Day Track
S025 2008-01-22 135 Review Track For 30-day Notice
S024 2007-05-01 Normal 180 Day Track
S023 2007-02-21 Normal 180 Day Track No User Fee
S022 2006-11-13 135 Review Track For 30-day Notice
S021 2006-11-06 30-day Notice
S020 2006-11-06 30-day Notice
S019 2006-11-06 30-day Notice
S018 2006-10-05 30-day Notice
S017 2006-10-04 30-day Notice
S016 2006-09-18 135 Review Track For 30-day Notice
S015 2006-09-18 30-day Notice
S014 2006-09-18 30-day Notice
S013 2006-09-18 30-day Notice
S012
S011 2006-09-18 135 Review Track For 30-day Notice
S010 2006-06-02 Normal 180 Day Track
S009 2006-05-01 Special (immediate Track)
S008 2006-01-09 Special (immediate Track)
S007 2005-10-17 Normal 180 Day Track No User Fee
S006 2005-05-19 30-day Notice
S005 2005-01-03 Normal 180 Day Track
S004 2004-05-11 Normal 180 Day Track
S003 2003-12-22 Normal 180 Day Track
S002 2003-10-06 Normal 180 Day Track
S001 2003-09-22 Normal 180 Day Track No User Fee

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