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.
Alternate supplier for the protective sheath component.
| Device | Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Medtronic Vascular |
| Date Received | 2021-01-25 |
| Decision Date | 2021-02-23 |
| PMA | P110013 |
| Supplement | S107 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110013 | Original Filing | |
| S117 | 2022-04-07 | Normal 180 Day Track No User Fee |
| S116 | 2022-03-23 | 30-day Notice |
| S115 | 2021-10-28 | 30-day Notice |
| S114 | 2021-08-02 | 30-day Notice |
| S113 | ||
| S112 | ||
| S111 | 2021-04-23 | Special (immediate Track) |
| S110 | 2021-04-12 | 30-day Notice |
| S109 | ||
| S108 | 2021-03-04 | 30-day Notice |
| S107 | 2021-01-25 | 30-day Notice |
| S106 | 2021-01-19 | 30-day Notice |
| S105 | 2020-12-07 | 30-day Notice |
| S104 | 2020-08-27 | 30-day Notice |
| S103 | ||
| S102 | 2020-04-17 | 30-day Notice |
| S101 | 2020-03-13 | 30-day Notice |
| S100 | 2019-08-29 | 30-day Notice |
| S099 | 2019-08-09 | 30-day Notice |
| S098 | ||
| S097 | ||
| S096 | ||
| S095 | ||
| S094 | 2019-01-09 | Normal 180 Day Track No User Fee |
| S093 | 2018-09-24 | 30-day Notice |
| S092 | 2018-09-24 | 30-day Notice |
| S091 | 2018-09-17 | Normal 180 Day Track No User Fee |
| S090 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S089 | 2018-03-19 | 30-day Notice |
| S088 | 2018-01-16 | Panel Track |
| S087 | 2017-12-18 | Real-time Process |
| S086 | 2017-11-22 | Normal 180 Day Track No User Fee |
| S085 | 2017-11-20 | 30-day Notice |
| S084 | 2017-10-12 | 30-day Notice |
| S083 | 2017-10-10 | 30-day Notice |
| S082 | 2017-09-14 | 30-day Notice |
| S081 | 2017-08-04 | 30-day Notice |
| S080 | 2017-07-03 | Real-time Process |
| S079 | 2017-05-26 | 30-day Notice |
| S078 | 2016-10-27 | 30-day Notice |
| S077 | 2016-10-11 | Real-time Process |
| S076 | 2016-09-02 | 30-day Notice |
| S075 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S074 | 2016-07-13 | 30-day Notice |
| S073 | 2016-06-22 | 30-day Notice |
| S072 | 2016-06-06 | 30-day Notice |
| S071 | 2016-05-23 | 30-day Notice |
| S070 | 2016-05-16 | 30-day Notice |
| S069 | 2016-05-12 | 30-day Notice |
| S068 | 2016-04-25 | 30-day Notice |
| S067 | 2016-04-22 | 135 Review Track For 30-day Notice |
| S066 | ||
| S065 | 2016-04-04 | 135 Review Track For 30-day Notice |
| S064 | 2016-03-15 | 30-day Notice |
| S063 | ||
| S062 | 2016-03-03 | 30-day Notice |
| S061 | 2016-02-08 | 30-day Notice |
| S060 | 2016-01-29 | 30-day Notice |
| S059 | 2016-01-27 | Normal 180 Day Track No User Fee |
| S058 | ||
| S057 | 2015-09-04 | 30-day Notice |
| S056 | 2015-08-21 | 30-day Notice |
| S055 | 2015-08-17 | 30-day Notice |
| S054 | 2015-07-20 | 30-day Notice |
| S053 | 2015-07-20 | 30-day Notice |
| S052 | 2015-05-27 | 30-day Notice |
| S051 | 2015-05-14 | 30-day Notice |
| S050 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S049 | 2014-12-18 | Normal 180 Day Track No User Fee |
| S048 | 2014-11-17 | 30-day Notice |
| S047 | 2014-11-10 | 30-day Notice |
| S046 | 2014-09-23 | Real-time Process |
| S045 | 2014-09-12 | 30-day Notice |
| S044 | 2014-08-20 | Normal 180 Day Track No User Fee |
| S043 | 2014-07-02 | 30-day Notice |
| S042 | 2014-06-25 | 135 Review Track For 30-day Notice |
| S041 | ||
| S040 | 2014-04-25 | 30-day Notice |
| S039 | 2014-04-03 | 30-day Notice |
| S038 | 2014-03-18 | 30-day Notice |
| S037 | 2014-03-13 | 30-day Notice |
| S036 | 2014-02-18 | 30-day Notice |
| S035 | 2014-02-12 | 30-day Notice |
| S034 | 2014-02-03 | Special (immediate Track) |
| S033 | 2013-12-23 | 30-day Notice |
| S032 | 2013-12-16 | 30-day Notice |
| S031 | 2013-11-22 | 30-day Notice |
| S030 | 2013-11-18 | 30-day Notice |
| S029 | 2013-11-15 | 30-day Notice |
| S028 | 2013-11-04 | Normal 180 Day Track No User Fee |
| S027 | 2013-09-26 | 30-day Notice |
| S026 | 2013-09-26 | 30-day Notice |
| S025 | 2013-08-19 | 30-day Notice |
| S024 | 2013-08-09 | 135 Review Track For 30-day Notice |
| S023 | 2013-08-02 | 30-day Notice |
| S022 | 2013-08-01 | 30-day Notice |
| S021 | 2013-08-01 | 135 Review Track For 30-day Notice |
| S020 | 2013-07-18 | 135 Review Track For 30-day Notice |
| S019 | 2013-07-01 | 30-day Notice |
| S018 | 2013-07-01 | 30-day Notice |
| S017 | 2013-04-05 | Normal 180 Day Track No User Fee |
| S016 | 2013-06-17 | Normal 180 Day Track No User Fee |
| S015 | 2013-06-10 | 135 Review Track For 30-day Notice |
| S014 | 2013-05-28 | 30-day Notice |
| S013 | 2013-04-30 | 30-day Notice |
| S012 | 2013-04-26 | 135 Review Track For 30-day Notice |
| S011 | 2013-04-10 | 135 Review Track For 30-day Notice |
| S010 | 2013-04-08 | 30-day Notice |
| S009 | 2013-03-14 | Special (immediate Track) |
| S008 | 2013-03-01 | 30-day Notice |
| S007 | 2013-02-19 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2012-07-09 | Panel Track |
| S004 | 2012-06-29 | 30-day Notice |
| S003 | 2012-04-27 | 30-day Notice |
| S002 | 2012-05-10 | Normal 180 Day Track |
| S001 | 2012-03-22 | 135 Review Track For 30-day Notice |