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 gore® excluder® iliac branch endoprosthesis (ibe device). This device is indicated for use with the gore® excluder® aaa endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1) adequate iliac/ femoral access; 2) minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe; 3) external iliac artery treatment diameter range of 6. 5 – 25 mm and seal zone length of at least 10 mm; 4) internal iliac artery treatment diameter range of 6. 5 – 13. 5 mm and seal zone length of at least 10 mm; and 5) adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components.
| Device | GORE EXCLUDER ILIAC BRANCH 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 | 2015-09-02 |
| Decision Date | 2016-02-29 |
| Notice Date | 2016-03-15 |
| PMA | P020004 |
| Supplement | S123 |
| Product Code | MIH |
| Docket Number | 16M-0928 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |