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.
| Device | Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS102 Date Received03/11/2022 Decision Date04/07/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-11 |
| Decision Date | 2022-04-07 |
| PMA | P100021 |
| Supplement | S102 |
| 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 PMA NumberP100021 Supplement NumberS102 Date Received03/11/2022 Decision Date04/07/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement for Implementation Of Changes To The Taper Tip Manufacturing And Inspection Processes At The Supplier And Updates To The Inspection Plan For The Taper Tip Assembly At Medtronic’s Receiving Inspection |
| 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 |