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.
An alternative storage facility for stability samples
Device | Resolute Onyx Zotarolimus-Eluting Coronary Stent System |
Generic Name | Coronary Drug-eluting Stent |
Applicant | MEDTRONIC VASCULAR |
Date Received | 2021-01-19 |
Decision Date | 2021-02-04 |
PMA | P160043 |
Supplement | S042 |
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 |