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 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
| 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 | 2017-05-23 |
| Decision Date | 2017-11-16 |
| Notice Date | 2017-11-21 |
| PMA | P160043 |
| Supplement | S001 |
| Product Code | NIQ |
| Docket Number | 17M-6650 |
| 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 |
|---|---|---|
| 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 |