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.
Additional verification of the date of manufacture and use by date for devices undergoing rework activities
| Device | Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2021-04-23 |
| Decision Date | 2021-05-21 |
| PMA | P100021 |
| Supplement | S091 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100021 | Original Filing | |
| S111 | 2022-11-29 | 30-day Notice |
| S110 | 2022-11-18 | 30-day Notice |
| S109 | 2022-11-01 | 30-day Notice |
| S108 | 2022-10-31 | 30-day Notice |
| S107 | 2022-09-28 | 30-day Notice |
| S106 | ||
| S105 | 2022-07-27 | 30-day Notice |
| S104 | 2022-04-15 | 30-day Notice |
| S103 | 2022-03-23 | 30-day Notice |
| S102 | 2022-03-11 | Special (immediate Track) |
| S101 | 2022-01-25 | 30-day Notice |
| S100 | 2022-01-10 | 30-day Notice |
| S099 | 2021-12-07 | 30-day Notice |
| S098 | 2021-12-07 | 30-day Notice |
| S097 | 2021-11-17 | 30-day Notice |
| S096 | 2021-10-20 | Special (immediate Track) |
| S095 | 2021-08-31 | 30-day Notice |
| S094 | 2021-07-27 | 30-day Notice |
| S093 | ||
| S092 | 2021-04-28 | Normal 180 Day Track No User Fee |
| S091 | 2021-04-23 | Special (immediate Track) |
| S090 | 2021-03-17 | 30-day Notice |
| S089 | ||
| S088 | 2021-03-04 | 30-day Notice |
| S087 | 2021-02-25 | 30-day Notice |
| S086 | ||
| S085 | 2020-10-26 | 30-day Notice |
| S084 | 2020-09-25 | 30-day Notice |
| S083 | 2020-09-04 | Normal 180 Day Track No User Fee |
| S082 | ||
| S081 | 2020-07-14 | 30-day Notice |
| S080 | 2020-03-05 | 30-day Notice |
| S079 | 2020-01-08 | 30-day Notice |
| S078 | 2019-09-17 | 30-day Notice |
| S077 | ||
| S076 | 2019-04-05 | 30-day Notice |
| S075 | 2019-01-22 | 30-day Notice |
| S074 | 2018-09-24 | 30-day Notice |
| S073 | 2018-09-24 | 30-day Notice |
| S072 | 2018-09-10 | Normal 180 Day Track No User Fee |
| S071 | 2018-04-05 | 30-day Notice |
| S070 | 2018-04-04 | 30-day Notice |
| S069 | 2018-01-03 | 30-day Notice |
| S068 | 2017-11-20 | 30-day Notice |
| S067 | 2017-07-24 | 30-day Notice |
| S066 | 2017-07-18 | 30-day Notice |
| S065 | 2017-07-14 | 30-day Notice |
| S064 | 2017-04-19 | 30-day Notice |
| S063 | 2017-04-03 | Panel Track |
| S062 | 2017-03-24 | 30-day Notice |
| S061 | ||
| S060 | 2017-01-04 | 30-day Notice |
| S059 | 2016-12-20 | 30-day Notice |
| S058 | 2016-10-06 | Normal 180 Day Track |
| S057 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S056 | ||
| S055 | 2016-07-13 | 30-day Notice |
| S054 | 2016-06-28 | 135 Review Track For 30-day Notice |
| S053 | 2016-05-26 | 30-day Notice |
| S052 | 2016-05-19 | 30-day Notice |
| S051 | 2016-02-02 | 30-day Notice |
| S050 | 2015-10-27 | 30-day Notice |
| S049 | 2015-08-10 | 30-day Notice |
| S048 | 2015-07-10 | 30-day Notice |
| S047 | 2015-04-14 | Special (immediate Track) |
| S046 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S045 | 2015-02-26 | Special (immediate Track) |
| S044 | 2014-11-21 | Special (immediate Track) |
| S043 | 2014-11-20 | 30-day Notice |
| S042 | 2014-11-07 | 30-day Notice |
| S041 | 2014-10-28 | Real-time Process |
| S040 | 2014-09-03 | 30-day Notice |
| S039 | 2014-07-25 | Real-time Process |
| S038 | 2014-06-09 | Special (immediate Track) |
| S037 | 2014-04-25 | 30-day Notice |
| S036 | 2014-04-15 | Special (immediate Track) |
| S035 | 2014-04-15 | Special (immediate Track) |
| S034 | 2014-04-10 | 30-day Notice |
| S033 | 2014-01-31 | 30-day Notice |
| S032 | 2013-12-26 | Normal 180 Day Track No User Fee |
| S031 | 2013-12-16 | 30-day Notice |
| S030 | 2013-11-15 | 30-day Notice |
| S029 | 2013-09-30 | 30-day Notice |
| S028 | 2013-08-14 | 30-day Notice |
| S027 | 2013-07-25 | Special (immediate Track) |
| S026 | 2013-05-28 | 30-day Notice |
| S025 | 2013-04-04 | 30-day Notice |
| S024 | 2013-03-20 | Normal 180 Day Track No User Fee |
| S023 | 2013-02-25 | 30-day Notice |
| S022 | 2012-10-22 | 30-day Notice |
| S021 | 2012-10-11 | Normal 180 Day Track |
| S020 | 2012-08-27 | 30-day Notice |
| S019 | 2012-06-12 | 30-day Notice |
| S018 | 2012-05-18 | Normal 180 Day Track No User Fee |
| S017 | 2012-05-09 | 30-day Notice |
| S016 | 2012-04-03 | 30-day Notice |
| S015 | 2012-03-22 | 135 Review Track For 30-day Notice |
| S014 | 2012-03-22 | 30-day Notice |
| S013 | 2012-01-30 | 30-day Notice |
| S012 | 2011-11-10 | Normal 180 Day Track No User Fee |
| S011 | 2011-11-02 | Normal 180 Day Track |
| S010 | 2011-08-18 | Special (immediate Track) |
| S009 | 2011-07-11 | 30-day Notice |
| S008 | 2011-04-21 | 30-day Notice |
| S007 | 2011-03-04 | 30-day Notice |
| S006 | 2011-03-01 | 30-day Notice |
| S005 | 2011-02-18 | 30-day Notice |
| S004 | 2011-02-14 | 135 Review Track For 30-day Notice |
| S003 | ||
| S002 | 2011-01-14 | Normal 180 Day Track No User Fee |
| S001 | 2011-01-12 | 30-day Notice |