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 endurant stent graft system. The device is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients with the following characteristics: 1) adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) proximal neck length of >= 10mm; 3) infrarenal neck angulation = 15 mm; 5) aortic neck diameters with a range of 19 to 32 mm; 6) iliac diameters with a range of 8 to 25 mm; and 7) morphology suitable for aneurysm repair.
| Device | MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2010-06-04 |
| Decision Date | 2010-12-16 |
| Notice Date | 2011-01-25 |
| PMA | P100021 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 11M-0040 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| 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 |
|---|---|---|
| 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 |