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 to introduce changes to the annual stability study design for the resolute onyx coronary stent system and resolute integrity coronary stent system.
| Device | Resolute Onyx Coronary Stent System |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | MEDTRONIC VASCULAR |
| Date Received | 2017-12-18 |
| Decision Date | 2018-03-15 |
| PMA | P160043 |
| Supplement | S011 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC VASCULAR 3576 Unocal Place santa Rosa, CA 95403 |
| 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 |