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.
Introduction of a manufacturing aid during the delivery system external handle assembly process.
| Device | ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II'S STENT GRAFT SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2015-08-10 |
| Decision Date | 2015-09-11 |
| PMA | P100021 |
| Supplement | S049 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| 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 |