GORE TAG THORACIC ENDOPROSTHESIS

FDA Premarket Approval P040043 S057

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

Modify the surface treatment of the nitinol stent component.

DeviceGORE TAG THORACIC ENDOPROSTHESIS
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. GORE & ASSOCIATES, INC.
Date Received2013-09-25
Decision Date2013-10-25
PMAP040043
SupplementS057
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address W. L. GORE & ASSOCIATES, INC. 3450 Kiltie Lane p.o. Box 2400 flagstaff, AZ 86003-2400

Supplemental Filings

Supplement NumberDateSupplement Type
P040043Original Filing
S132 2022-12-15 Special (immediate Track)
S131 2022-09-06 30-day Notice
S130 2022-01-20 30-day Notice
S129 2021-05-18 30-day Notice
S128 2021-04-27 30-day Notice
S127 2021-04-26 30-day Notice
S126 2021-04-06 30-day Notice
S125 2021-03-29 30-day Notice
S124 2021-02-23 30-day Notice
S123
S122
S121 2021-01-13 30-day Notice
S120 2020-09-16 Special (immediate Track)
S119 2020-08-04 30-day Notice
S118
S117 2020-07-06 30-day Notice
S116 2020-07-01 30-day Notice
S115 2020-06-09 30-day Notice
S114 2020-03-02 30-day Notice
S113 2019-10-02 30-day Notice
S112
S111 2019-04-15 30-day Notice
S110 2019-03-12 135 Review Track For 30-day Notice
S109 2019-03-01 30-day Notice
S108 2018-12-07 30-day Notice
S107 2018-11-30 30-day Notice
S106 2018-11-02 Normal 180 Day Track
S105 2018-09-21 30-day Notice
S104 2018-09-18 30-day Notice
S103 2018-06-29 30-day Notice
S102 2018-06-07 30-day Notice
S101 2018-06-01 30-day Notice
S100
S099 2018-04-17 30-day Notice
S098 2018-02-20 30-day Notice
S097 2017-11-03 30-day Notice
S096 2017-10-02 Special (immediate Track)
S095 2017-08-29 30-day Notice
S094 2017-07-12 30-day Notice
S093 2017-05-26 30-day Notice
S092 2017-05-17 30-day Notice
S091
S090 2016-11-18 30-day Notice
S089 2016-11-18 30-day Notice
S088
S087 2016-10-03 30-day Notice
S086 2016-07-19 30-day Notice
S085 2016-04-18 30-day Notice
S084 2016-03-24 30-day Notice
S083 2016-03-14 30-day Notice
S082 2016-01-28 30-day Notice
S081 2016-01-15 30-day Notice
S080 2016-01-06 30-day Notice
S079 2015-12-09 30-day Notice
S078 2015-11-20 30-day Notice
S077 2015-08-11 30-day Notice
S076 2015-08-07 30-day Notice
S075 2015-07-21 30-day Notice
S074 2015-05-14 30-day Notice
S073 2015-04-10 30-day Notice
S072 2015-03-02 30-day Notice
S071 2014-12-22 30-day Notice
S070 2014-11-25 30-day Notice
S069 2014-09-29 30-day Notice
S068 2014-09-19 30-day Notice
S067 2014-07-18 Normal 180 Day Track No User Fee
S066 2014-06-04 30-day Notice
S065 2014-06-04 30-day Notice
S064 2014-06-04 30-day Notice
S063 2014-06-04 30-day Notice
S062 2014-05-23 30-day Notice
S061 2014-04-28 30-day Notice
S060 2014-01-14 Normal 180 Day Track
S059 2013-10-22 30-day Notice
S058
S057 2013-09-25 30-day Notice
S056 2013-07-12 30-day Notice
S055 2013-06-14 30-day Notice
S054 2013-06-12 30-day Notice
S053 2013-05-21 30-day Notice
S052 2013-04-02 30-day Notice
S051 2013-03-14 Panel Track
S050 2012-11-27 30-day Notice
S049 2012-11-06 30-day Notice
S048 2012-05-01 30-day Notice
S047 2012-04-20 135 Review Track For 30-day Notice
S046 2012-03-05 30-day Notice
S045 2012-02-07 Real-time Process
S044
S043 2011-10-07 30-day Notice
S042 2011-09-26 30-day Notice
S041 2011-09-01 135 Review Track For 30-day Notice
S040 2011-07-01 Panel Track
S039 2011-03-01 Normal 180 Day Track
S038 2011-02-16 30-day Notice
S037 2010-09-02 Normal 180 Day Track No User Fee
S036 2010-08-17 30-day Notice
S035 2010-07-07 30-day Notice
S034 2010-01-13 30-day Notice
S033 2010-01-13 Real-time Process
S032 2009-10-23 30-day Notice
S031 2009-09-24 Normal 180 Day Track
S030 2009-06-30 30-day Notice
S029 2009-06-24 135 Review Track For 30-day Notice
S028
S027 2009-02-02 30-day Notice
S026 2008-11-19 30-day Notice
S025 2008-09-03 30-day Notice
S024 2008-08-20 Real-time Process
S023 2008-05-30 Normal 180 Day Track No User Fee
S022 2008-02-11 30-day Notice
S021 2008-01-08 30-day Notice
S020 2007-11-06 30-day Notice
S019 2007-10-22 Normal 180 Day Track
S018 2007-09-12 Real-time Process
S017 2007-08-14 135 Review Track For 30-day Notice
S016 2007-08-09 135 Review Track For 30-day Notice
S015 2007-05-14 30-day Notice
S014 2007-05-11 30-day Notice
S013 2007-03-08 135 Review Track For 30-day Notice
S012 2006-12-06 30-day Notice
S011 2006-08-25 30-day Notice
S010 2006-05-18 Special (immediate Track)
S009 2006-02-13 30-day Notice
S008 2005-12-20 Special (immediate Track)
S007 2005-11-03 30-day Notice
S006 2005-07-19 Normal 180 Day Track No User Fee
S005 2005-05-24 30-day Notice
S004 2005-04-21 30-day Notice
S003 2005-05-04 30-day Notice
S002 2005-04-21 30-day Notice
S001 2005-04-14 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00733132613748 P040043 059
00733132613731 P040043 059
00733132613724 P040043 059
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H373TGU2828103 P040043 059
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H373TGU2626103 P040043 059
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00733132617814 P040043 059
00733132646852 P040043 106
00733132646845 P040043 106
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00733132646807 P040043 106
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00733132647002 P040043 106
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00733132646937 P040043 106
00733132646920 P040043 106
00733132646760 P040043 106

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