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.
Introduce software for monitoring the controlled environment areas (ceas) at the empalme, mexico manufacturing facility.
| Device | Resolute Integrity Coronary Stent Systems |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Medtronic Vascular |
| Date Received | 2017-11-20 |
| Decision Date | 2017-12-20 |
| PMA | P110013 |
| Supplement | S085 |
| Product Code | NIQ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |