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.
Add a manufacturing line at a packaging component supplier.
| 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 | 2019-04-15 |
| Decision Date | 2019-05-13 |
| PMA | P020004 |
| Supplement | S165 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |