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.
Transfer of component extrusion manufacturing operations from the santa rosa to the danvers site.
| Device | Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx) |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | MEDTRONIC VASCULAR |
| Date Received | 2021-04-12 |
| Decision Date | 2021-05-11 |
| PMA | P160043 |
| Supplement | S046 |
| Product Code | NIQ |
| 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 |
|---|---|---|
| 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 |