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 the resolute integrity zotarolimus-eluting coronary stent system. This device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, withsymptomatic ischemic heart disease due to de novo lesions of length
| Device | RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Medtronic Vascular |
| Date Received | 2012-07-09 |
| Decision Date | 2013-02-22 |
| Notice Date | 2013-03-22 |
| PMA | P110013 |
| Supplement | S005 |
| Product Code | NIQ |
| Docket Number | 13M-0343 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |