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.
| Device | GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS132 Date Received12/15/2022 Decision Date01/12/2023 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-12-15 |
| Decision Date | 2023-01-12 |
| PMA | P040043 |
| Supplement | S132 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate 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 PMA NumberP040043 Supplement NumberS132 Date Received12/15/2022 Decision Date01/12/2023 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Implementation Of Updates To The Warnings And MR Compatibility Information In The Instructions For Use (IFU) And Patient Implant Card |
| 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 |