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 changes to the instructions for use to emphasize the appropriate withdrawal procedures for the delivery catheter and sheath if resistance is felt during removal. These changes included modifications to the directions for use as well as the addition of a warning/ precaution regarding the potential adverse events that may be associated with forcibly withdrawing the delivery catheter through the introducer sheath.
| 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 | 2007-05-21 |
| Decision Date | 2007-06-26 |
| PMA | P020004 |
| Supplement | S023 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |