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 tag thoracic endoprosthesis. This device is intended for endovascular repair of all lesions of the descending thoracic aorta, including:1) isolated lesions in patients who have appropriate anatomy, including:a) adequate iliac i femoral access;b) aortic inner diameter in the range of 16-42 mm; and c) > 20 mm non-aneurysmal aorta proximal and distal to the lesion. 2) type b dissections in patients who have appropriate anatomy, including:a) adequate iliac i femoral access;b) > 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected; andc) diameter at proximal extent of proximal landing zone in the range of 16-42 mm.
| Device | GORE TAG THORACIC 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 | 2013-03-14 |
| Decision Date | 2013-09-10 |
| Notice Date | 2013-10-24 |
| PMA | P040043 |
| Supplement | S051 |
| Product Code | MIH |
| Docket Number | 13M-1323 |
| 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. 3450 Kiltie Lane p.o. Box 2400 flagstaff, AZ 86003-2400 |
| 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 |
|---|---|---|
| P040043 | Original Filing | |
| S132 | 2022-12-15 | Special (immediate Track) |
| S131 | 2022-09-06 | 30-day Notice |
| S130 | 2022-01-20 | 30-day Notice |
| S129 | 2021-05-18 | 30-day Notice |
| S128 | 2021-04-27 | 30-day Notice |
| S127 | 2021-04-26 | 30-day Notice |
| S126 | 2021-04-06 | 30-day Notice |
| S125 | 2021-03-29 | 30-day Notice |
| S124 | 2021-02-23 | 30-day Notice |
| S123 | ||
| S122 | ||
| S121 | 2021-01-13 | 30-day Notice |
| S120 | 2020-09-16 | Special (immediate Track) |
| S119 | 2020-08-04 | 30-day Notice |
| S118 | ||
| S117 | 2020-07-06 | 30-day Notice |
| S116 | 2020-07-01 | 30-day Notice |
| S115 | 2020-06-09 | 30-day Notice |
| S114 | 2020-03-02 | 30-day Notice |
| S113 | 2019-10-02 | 30-day Notice |
| S112 | ||
| S111 | 2019-04-15 | 30-day Notice |
| S110 | 2019-03-12 | 135 Review Track For 30-day Notice |
| S109 | 2019-03-01 | 30-day Notice |
| S108 | 2018-12-07 | 30-day Notice |
| S107 | 2018-11-30 | 30-day Notice |
| S106 | 2018-11-02 | Normal 180 Day Track |
| S105 | 2018-09-21 | 30-day Notice |
| S104 | 2018-09-18 | 30-day Notice |
| S103 | 2018-06-29 | 30-day Notice |
| S102 | 2018-06-07 | 30-day Notice |
| S101 | 2018-06-01 | 30-day Notice |
| S100 | ||
| S099 | 2018-04-17 | 30-day Notice |
| S098 | 2018-02-20 | 30-day Notice |
| S097 | 2017-11-03 | 30-day Notice |
| S096 | 2017-10-02 | Special (immediate Track) |
| S095 | 2017-08-29 | 30-day Notice |
| S094 | 2017-07-12 | 30-day Notice |
| S093 | 2017-05-26 | 30-day Notice |
| S092 | 2017-05-17 | 30-day Notice |
| S091 | ||
| S090 | 2016-11-18 | 30-day Notice |
| S089 | 2016-11-18 | 30-day Notice |
| S088 | ||
| S087 | 2016-10-03 | 30-day Notice |
| S086 | 2016-07-19 | 30-day Notice |
| S085 | 2016-04-18 | 30-day Notice |
| S084 | 2016-03-24 | 30-day Notice |
| S083 | 2016-03-14 | 30-day Notice |
| S082 | 2016-01-28 | 30-day Notice |
| S081 | 2016-01-15 | 30-day Notice |
| S080 | 2016-01-06 | 30-day Notice |
| S079 | 2015-12-09 | 30-day Notice |
| S078 | 2015-11-20 | 30-day Notice |
| S077 | 2015-08-11 | 30-day Notice |
| S076 | 2015-08-07 | 30-day Notice |
| S075 | 2015-07-21 | 30-day Notice |
| S074 | 2015-05-14 | 30-day Notice |
| S073 | 2015-04-10 | 30-day Notice |
| S072 | 2015-03-02 | 30-day Notice |
| S071 | 2014-12-22 | 30-day Notice |
| S070 | 2014-11-25 | 30-day Notice |
| S069 | 2014-09-29 | 30-day Notice |
| S068 | 2014-09-19 | 30-day Notice |
| S067 | 2014-07-18 | Normal 180 Day Track No User Fee |
| S066 | 2014-06-04 | 30-day Notice |
| S065 | 2014-06-04 | 30-day Notice |
| S064 | 2014-06-04 | 30-day Notice |
| S063 | 2014-06-04 | 30-day Notice |
| S062 | 2014-05-23 | 30-day Notice |
| S061 | 2014-04-28 | 30-day Notice |
| S060 | 2014-01-14 | Normal 180 Day Track |
| S059 | 2013-10-22 | 30-day Notice |
| S058 | ||
| S057 | 2013-09-25 | 30-day Notice |
| S056 | 2013-07-12 | 30-day Notice |
| S055 | 2013-06-14 | 30-day Notice |
| S054 | 2013-06-12 | 30-day Notice |
| S053 | 2013-05-21 | 30-day Notice |
| S052 | 2013-04-02 | 30-day Notice |
| S051 | 2013-03-14 | Panel Track |
| S050 | 2012-11-27 | 30-day Notice |
| S049 | 2012-11-06 | 30-day Notice |
| S048 | 2012-05-01 | 30-day Notice |
| S047 | 2012-04-20 | 135 Review Track For 30-day Notice |
| S046 | 2012-03-05 | 30-day Notice |
| S045 | 2012-02-07 | Real-time Process |
| S044 | ||
| S043 | 2011-10-07 | 30-day Notice |
| S042 | 2011-09-26 | 30-day Notice |
| S041 | 2011-09-01 | 135 Review Track For 30-day Notice |
| S040 | 2011-07-01 | Panel Track |
| S039 | 2011-03-01 | Normal 180 Day Track |
| S038 | 2011-02-16 | 30-day Notice |
| S037 | 2010-09-02 | Normal 180 Day Track No User Fee |
| S036 | 2010-08-17 | 30-day Notice |
| S035 | 2010-07-07 | 30-day Notice |
| S034 | 2010-01-13 | 30-day Notice |
| S033 | 2010-01-13 | Real-time Process |
| S032 | 2009-10-23 | 30-day Notice |
| S031 | 2009-09-24 | Normal 180 Day Track |
| S030 | 2009-06-30 | 30-day Notice |
| S029 | 2009-06-24 | 135 Review Track For 30-day Notice |
| S028 | ||
| S027 | 2009-02-02 | 30-day Notice |
| S026 | 2008-11-19 | 30-day Notice |
| S025 | 2008-09-03 | 30-day Notice |
| S024 | 2008-08-20 | Real-time Process |
| S023 | 2008-05-30 | Normal 180 Day Track No User Fee |
| S022 | 2008-02-11 | 30-day Notice |
| S021 | 2008-01-08 | 30-day Notice |
| S020 | 2007-11-06 | 30-day Notice |
| S019 | 2007-10-22 | Normal 180 Day Track |
| S018 | 2007-09-12 | Real-time Process |
| S017 | 2007-08-14 | 135 Review Track For 30-day Notice |
| S016 | 2007-08-09 | 135 Review Track For 30-day Notice |
| S015 | 2007-05-14 | 30-day Notice |
| S014 | 2007-05-11 | 30-day Notice |
| S013 | 2007-03-08 | 135 Review Track For 30-day Notice |
| S012 | 2006-12-06 | 30-day Notice |
| S011 | 2006-08-25 | 30-day Notice |
| S010 | 2006-05-18 | Special (immediate Track) |
| S009 | 2006-02-13 | 30-day Notice |
| S008 | 2005-12-20 | Special (immediate Track) |
| S007 | 2005-11-03 | 30-day Notice |
| S006 | 2005-07-19 | Normal 180 Day Track No User Fee |
| S005 | 2005-05-24 | 30-day Notice |
| S004 | 2005-04-21 | 30-day Notice |
| S003 | 2005-05-04 | 30-day Notice |
| S002 | 2005-04-21 | 30-day Notice |
| S001 | 2005-04-14 | 30-day Notice |