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 addition of five (5) short bifurcated stent graft configurations to the endurant ii stent graft system, which are called endurant iis stent grafts (also referred to as endurant iis). The device, as modified, will be marketed under the trade name endurant iis stent graft system. The endurant ii/endurant iis bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. The endurant ii aorto-uni-iliac (aui) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of bifurcated stent graft. The endurant ii/endurant iis stent graft system is indicated for use 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 >=10 mm;3) infrarenal neck angulation =15 mm; 6) iliac diameters with a range of 8 to 25 mm; and 7) morphology suitable for aneurysm repair.
| Device | ENDURANT IIS STENT GRAFT SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2014-07-25 |
| Decision Date | 2014-10-23 |
| PMA | P100021 |
| Supplement | S039 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |