This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the resolute onyx zotarolimus-eluting coronary stent system. This device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length less than or equal to 35 mm in native coronary arteries with reference vessel diameters of 2. 25 mm to 5. 0 mm.
| Device | RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | MEDTRONIC VASCULAR |
| Date Received | 2016-09-27 |
| Decision Date | 2017-04-28 |
| Notice Date | 2017-05-02 |
| PMA | P160043 |
| Supplement | S |
| Product Code | NIQ |
| Docket Number | 17M-2767 |
| Advisory Committee | Cardiovascular |
| 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 |
|---|---|---|
| P160043 | Original Filing | |
| S064 | 2022-11-29 | 30-day Notice |
| S063 | 2022-11-18 | 30-day Notice |
| S062 | 2022-10-31 | 30-day Notice |
| S061 | 2022-06-03 | 30-day Notice |
| S060 | ||
| S059 | 2022-03-23 | 30-day Notice |
| S058 | ||
| S057 | 2021-12-16 | Special (immediate Track) |
| S056 | 2021-10-25 | 30-day Notice |
| S055 | ||
| S054 | 2021-08-02 | 30-day Notice |
| S053 | ||
| S052 | 2021-07-16 | 30-day Notice |
| S051 | 2021-07-15 | 30-day Notice |
| S050 | 2021-06-30 | 30-day Notice |
| S049 | ||
| S048 | ||
| S047 | 2021-04-23 | Special (immediate Track) |
| S046 | 2021-04-12 | 30-day Notice |
| S045 | ||
| S044 | 2021-03-04 | 30-day Notice |
| S043 | 2021-01-25 | 30-day Notice |
| S042 | 2021-01-19 | 30-day Notice |
| S041 | ||
| S040 | 2020-12-07 | 30-day Notice |
| S039 | ||
| S038 | 2020-08-27 | 30-day Notice |
| S037 | ||
| S036 | ||
| S035 | 2020-04-17 | 30-day Notice |
| S034 | ||
| S033 | 2020-03-13 | 30-day Notice |
| S032 | ||
| S031 | 2020-02-25 | Real-time Process |
| S030 | ||
| S029 | 2019-11-18 | 30-day Notice |
| S028 | 2019-08-29 | 30-day Notice |
| S027 | ||
| S026 | 2019-08-09 | 30-day Notice |
| S025 | ||
| S024 | ||
| S023 | 2019-03-28 | 30-day Notice |
| S022 | 2019-02-25 | 30-day Notice |
| S021 | 2019-01-09 | Normal 180 Day Track No User Fee |
| S020 | 2018-09-24 | 30-day Notice |
| S019 | 2018-09-24 | 30-day Notice |
| S018 | 2018-09-13 | 135 Review Track For 30-day Notice |
| S017 | 2018-09-04 | 30-day Notice |
| S016 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S015 | 2018-03-19 | 30-day Notice |
| S014 | 2018-03-19 | 30-day Notice |
| S013 | 2018-02-13 | Normal 180 Day Track |
| S012 | 2018-01-16 | Panel Track |
| S011 | 2017-12-18 | Real-time Process |
| S010 | 2017-10-12 | 30-day Notice |
| S009 | 2017-10-10 | 30-day Notice |
| S008 | 2017-10-05 | 30-day Notice |
| S007 | 2017-09-25 | Real-time Process |
| S006 | 2017-08-16 | 30-day Notice |
| S005 | 2017-08-04 | 30-day Notice |
| S004 | 2017-07-10 | 30-day Notice |
| S003 | 2017-06-19 | 30-day Notice |
| S002 | 2017-05-26 | 30-day Notice |
| S001 | 2017-05-23 | Panel Track |