Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System

FDA Premarket Approval P040043 S115

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

Implementation of updates to the sleeve trimming procedure and addition of inspection for damage to the deployment line of the gore tag thoracic stent graft with active control system

DeviceGore TAG Thoracic Stent Graft with ACTIVE CONTROL System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. GORE & ASSOCIATES, INC.
Date Received2020-06-09
Decision Date2020-07-09
PMAP040043
SupplementS115
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
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

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00733132646760 P040043 106

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