ZENITH AAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P020018 S038

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

Alternate supplier of graft material.

DeviceZENITH AAA ENDOVASCULAR GRAFT
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCOOK, INC.
Date Received2011-05-03
Decision Date2011-05-17
PMAP020018
SupplementS038
Product CodeMIH
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
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
S060 2021-07-23 Normal 180 Day Track No User Fee
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

NIH GUDID Devices

Device IDPMASupp
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10827002325477 P020018 040

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