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 a sterilization site located at synergy health sterilization uk ltd in daventry, united kingdom, nn11 8rb.
Device | ENDURANT II STENT GRAFT SYSTEM |
Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | Medtronic Vascular |
Date Received | 2013-03-20 |
Decision Date | 2013-05-03 |
PMA | P100021 |
Supplement | S024 |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location 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 |