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.
Which requested approval to implement changes to your divisional bacterial endotoxin test parameters using the limulus amebocyte lysate test methodology
| 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 | 2019-03-12 |
| Decision Date | 2019-10-02 |
| PMA | P020004 |
| Supplement | S164 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 |