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.
Approval for the modification of the delivery system for the following device components of the gore excluder aaa endoprosthesis on the sim-pull (original) and c3 (emds) catheters in order to lower their delivery profiles as outlined below: 1) 16, 18 and 20 mm contralateral legs from 18 fr to 12 fr; 2) 23 mm contralateral leg from 18 fr to 14 fr; 3) 27 mm colateral leg from 18 fr to 15 fr; 4) 23, 26, 28. 5 mm aortic extenders from 18 fr to 16 fr; 5) 32 mm aortic extender from 20 fr to 17 fr; 6) 31 mm trunk-ipsilateral leg with sim-pull delivery system from 20 fr to 18 fr and 7) 31 mm trunk-ipsilateral leg with c3 delivery system from 20 fr to 18 fr.
Device | GORE EXCLUDER AAA ENDOPROSTHESIS |
Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | W.L. GORE & ASSOCIATES,INC |
Date Received | 2012-10-04 |
Decision Date | 2012-11-20 |
PMA | P020004 |
Supplement | S075 |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway phoenix, AZ 85085 |
Supplement Number | Date | Supplement Type |
---|---|---|
P020004 | Original Filing | |
S193 | 2022-10-21 | 30-day Notice |
S192 | 2022-09-06 | 30-day Notice |
S191 | 2022-08-12 | 30-day Notice |
S190 | 2022-08-01 | 30-day Notice |
S189 | 2022-02-01 | Normal 180 Day Track No User Fee |
S188 | 2022-01-25 | 30-day Notice |
S187 | ||
S186 | 2021-11-17 | 30-day Notice |
S185 | ||
S184 | 2021-09-30 | 30-day Notice |
S183 | 2021-07-16 | 30-day Notice |
S182 | ||
S181 | 2021-04-06 | 30-day Notice |
S180 | 2021-02-23 | 30-day Notice |
S179 | ||
S178 | ||
S177 | 2021-01-13 | 30-day Notice |
S176 | 2020-08-17 | 30-day Notice |
S175 | 2020-07-02 | 30-day Notice |
S174 | 2020-03-02 | 30-day Notice |
S173 | 2020-02-03 | 30-day Notice |
S172 | 2019-12-09 | Special (immediate Track) |
S171 | 2019-09-27 | 30-day Notice |
S170 | 2019-09-13 | 30-day Notice |
S169 | ||
S168 | 2019-08-30 | 30-day Notice |
S167 | ||
S166 | ||
S165 | 2019-04-15 | 30-day Notice |
S164 | 2019-03-12 | 135 Review Track For 30-day Notice |
S163 | 2019-03-01 | 30-day Notice |
S162 | 2018-12-07 | 30-day Notice |
S161 | 2018-11-16 | 30-day Notice |
S160 | 2018-11-14 | 30-day Notice |
S159 | 2018-09-26 | 30-day Notice |
S158 | 2018-09-18 | 30-day Notice |
S157 | 2018-09-12 | 30-day Notice |
S156 | 2018-06-29 | 30-day Notice |
S155 | 2018-06-07 | 30-day Notice |
S154 | 2018-06-01 | 30-day Notice |
S153 | ||
S152 | 2018-04-17 | 30-day Notice |
S151 | 2018-02-21 | 30-day Notice |
S150 | 2018-02-20 | 30-day Notice |
S149 | 2017-11-03 | 30-day Notice |
S148 | 2017-09-21 | 30-day Notice |
S147 | 2017-08-29 | 30-day Notice |
S146 | 2017-07-12 | 30-day Notice |
S145 | 2017-06-12 | 30-day Notice |
S144 | 2017-05-26 | 30-day Notice |
S143 | 2017-05-17 | 30-day Notice |
S142 | ||
S141 | 2016-11-21 | 30-day Notice |
S140 | 2016-11-21 | 30-day Notice |
S139 | 2016-11-18 | 30-day Notice |
S138 | 2016-10-03 | 30-day Notice |
S137 | 2016-08-02 | Normal 180 Day Track No User Fee |
S136 | 2016-07-07 | Real-time Process |
S135 | 2016-07-01 | 30-day Notice |
S134 | 2016-06-24 | 30-day Notice |
S133 | 2016-06-17 | 30-day Notice |
S132 | 2016-06-07 | 30-day Notice |
S131 | 2016-05-10 | 30-day Notice |
S130 | 2016-04-08 | 30-day Notice |
S129 | 2016-03-11 | 30-day Notice |
S128 | 2016-03-11 | 30-day Notice |
S127 | 2016-03-11 | 30-day Notice |
S126 | 2016-02-24 | Real-time Process |
S125 | 2016-01-29 | 30-day Notice |
S124 | 2015-11-20 | 30-day Notice |
S123 | 2015-09-02 | Panel Track |
S122 | 2015-08-24 | 30-day Notice |
S121 | 2015-08-24 | 30-day Notice |
S120 | 2015-07-21 | 30-day Notice |
S119 | 2015-06-22 | 30-day Notice |
S118 | 2015-06-09 | 30-day Notice |
S117 | 2015-06-04 | 30-day Notice |
S116 | 2015-05-14 | 30-day Notice |
S115 | 2015-04-30 | 30-day Notice |
S114 | 2015-04-27 | 30-day Notice |
S113 | 2015-04-08 | 30-day Notice |
S112 | 2015-03-31 | 30-day Notice |
S111 | 2015-03-02 | 30-day Notice |
S110 | 2014-12-22 | 30-day Notice |
S109 | 2014-10-06 | 30-day Notice |
S108 | 2014-10-03 | 30-day Notice |
S107 | ||
S106 | 2014-09-29 | 30-day Notice |
S105 | 2014-09-19 | 30-day Notice |
S104 | 2014-09-19 | 30-day Notice |
S103 | 2014-08-01 | 30-day Notice |
S102 | 2014-06-23 | 30-day Notice |
S101 | 2014-06-04 | 30-day Notice |
S100 | 2014-06-04 | 30-day Notice |
S099 | 2014-06-04 | 30-day Notice |
S098 | 2014-06-04 | 30-day Notice |
S097 | 2014-06-03 | 30-day Notice |
S096 | 2014-05-23 | 30-day Notice |
S095 | 2014-05-23 | 30-day Notice |
S094 | 2014-04-28 | 30-day Notice |
S093 | 2014-04-02 | 30-day Notice |
S092 | 2014-03-25 | Real-time Process |
S091 | 2014-01-17 | 30-day Notice |
S090 | ||
S089 | 2013-12-23 | 30-day Notice |
S088 | 2013-10-22 | 30-day Notice |
S087 | 2013-09-09 | 30-day Notice |
S086 | 2013-07-12 | 30-day Notice |
S085 | 2013-07-16 | Real-time Process |
S084 | 2013-06-14 | 30-day Notice |
S083 | 2013-06-12 | 30-day Notice |
S082 | 2013-05-21 | 30-day Notice |
S081 | 2013-04-02 | 30-day Notice |
S080 | 2012-11-29 | 30-day Notice |
S079 | 2012-11-27 | 30-day Notice |
S078 | 2012-11-21 | 30-day Notice |
S077 | 2012-11-13 | 30-day Notice |
S076 | 2012-11-06 | 30-day Notice |
S075 | 2012-10-04 | Real-time Process |
S074 | 2012-08-13 | Normal 180 Day Track |
S073 | 2012-05-01 | 30-day Notice |
S072 | 2012-04-20 | 135 Review Track For 30-day Notice |
S071 | 2012-03-30 | 30-day Notice |
S070 | 2012-02-07 | Real-time Process |
S069 | ||
S068 | 2011-12-19 | 30-day Notice |
S067 | 2011-11-25 | 30-day Notice |
S066 | 2011-10-07 | 30-day Notice |
S065 | 2011-09-26 | 30-day Notice |
S064 | 2011-09-15 | Real-time Process |
S063 | 2011-05-11 | 30-day Notice |
S062 | 2011-05-04 | Normal 180 Day Track No User Fee |
S061 | 2011-03-14 | 30-day Notice |
S060 | 2011-02-28 | 30-day Notice |
S059 | 2011-02-16 | 30-day Notice |
S058 | 2011-01-31 | 30-day Notice |
S057 | 2010-11-15 | 30-day Notice |
S056 | 2010-11-12 | 30-day Notice |
S055 | 2010-08-17 | 30-day Notice |
S054 | 2010-07-07 | 30-day Notice |
S053 | 2010-05-12 | 135 Review Track For 30-day Notice |
S052 | 2010-05-06 | Normal 180 Day Track |
S051 | 2010-03-12 | 30-day Notice |
S050 | 2010-03-12 | Real-time Process |
S049 | 2009-12-17 | 135 Review Track For 30-day Notice |
S048 | 2009-10-23 | 30-day Notice |
S047 | 2009-07-22 | 30-day Notice |
S046 | 2009-06-30 | 30-day Notice |
S045 | 2009-06-24 | 135 Review Track For 30-day Notice |
S044 | 2009-06-17 | 30-day Notice |
S043 | 2009-02-02 | 30-day Notice |
S042 | 2009-01-26 | 30-day Notice |
S041 | 2009-01-14 | Real-time Process |
S040 | 2008-11-24 | Normal 180 Day Track No User Fee |
S039 | 2008-11-03 | Normal 180 Day Track |
S038 | 2008-10-10 | 30-day Notice |
S037 | 2008-09-03 | 30-day Notice |
S036 | 2008-05-08 | 30-day Notice |
S035 | 2008-05-02 | Normal 180 Day Track No User Fee |
S034 | 2008-04-30 | 135 Review Track For 30-day Notice |
S033 | 2008-01-08 | 30-day Notice |
S032 | 2007-11-06 | 30-day Notice |
S031 | 2007-10-15 | Real-time Process |
S030 | 2007-10-09 | 30-day Notice |
S029 | 2007-09-20 | 30-day Notice |
S028 | 2007-09-12 | Real-time Process |
S027 | 2007-06-22 | 135 Review Track For 30-day Notice |
S026 | 2007-06-18 | 135 Review Track For 30-day Notice |
S025 | 2007-06-08 | 30-day Notice |
S024 | 2007-05-21 | Real-time Process |
S023 | 2007-05-21 | Special (immediate Track) |
S022 | 2007-05-11 | 30-day Notice |
S021 | 2007-04-05 | 30-day Notice |
S020 | 2007-03-22 | 30-day Notice |
S019 | 2007-03-08 | 135 Review Track For 30-day Notice |
S018 | 2006-12-06 | 30-day Notice |
S017 | ||
S016 | 2006-11-06 | 30-day Notice |
S015 | 2006-08-25 | 30-day Notice |
S014 | 2005-11-04 | 30-day Notice |
S013 | 2005-05-24 | 30-day Notice |
S012 | 2005-05-12 | 30-day Notice |
S011 | 2005-05-06 | Normal 180 Day Track |
S010 | 2005-01-25 | 135 Review Track For 30-day Notice |
S009 | ||
S008 | 2004-11-10 | 30-day Notice |
S007 | 2004-06-17 | Normal 180 Day Track No User Fee |
S006 | 2004-05-10 | Normal 180 Day Track |
S005 | 2003-09-02 | Normal 180 Day Track |
S004 | 2003-05-27 | Normal 180 Day Track |
S003 | 2003-01-31 | Normal 180 Day Track |
S002 | 2003-01-03 | Normal 180 Day Track |
S001 | 2002-12-31 | 30-day Notice |