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. The device is intended for endovascular repair of isolated lesions (not including dissections) of the descending thoracic aorta, in patients who have appropriate anatomy including adequate iliac/femoral access, aortic inner diameter in the range of 16-42 mm, and >= 20 mm non-aneurysmal aorta proximal and distal to the lesion.
| Device | GORE TAG THORACIC ENDOPROSTHESIS |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | W. L. GORE & ASSOCIATES, INC. |
| Date Received | 2011-07-01 |
| Decision Date | 2012-01-13 |
| Notice Date | 2012-01-19 |
| PMA | P040043 |
| Supplement | S040 |
| Product Code | MIH |
| Docket Number | 12M-0056 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W. L. GORE & ASSOCIATES, INC. 3450 Kiltie Lane p.o. Box 2400 flagstaff, AZ 86003-2400 |
| 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 |