This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the tag thoracic endoprosthesis and delivery catheter. The device is intended for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy including: 1) adequate iliac/femoral access. 2) aortic inner diameter in the range of 23-37 mm. 3) >=2 cm non-aneurysmal aorta proximal and distal to the aneurysm.
| 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 | 2004-10-04 |
| Decision Date | 2005-03-23 |
| Notice Date | 2005-08-12 |
| PMA | P040043 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 05M-0320 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| 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 |
| 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 |