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.
A source change for an acid solution used during the stent manufacturing
Device | Orsiro Sirolimus Eluting Coronary Stent System |
Generic Name | Coronary Drug-eluting Stent |
Applicant | Biotronik, Inc |
Date Received | 2021-06-14 |
Decision Date | 2021-07-13 |
PMA | P170030 |
Supplement | S017 |
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 | Biotronik, Inc 6024 Jean Road lake Oswego, OR 97035 |
Supplement Number | Date | Supplement Type |
---|---|---|
P170030 | Original Filing | |
S026 | 2022-07-07 | 30-day Notice |
S025 | ||
S024 | 2022-06-21 | 30-day Notice |
S023 | ||
S022 | ||
S021 | 2022-01-31 | 30-day Notice |
S020 | 2021-11-09 | 30-day Notice |
S019 | ||
S018 | 2021-07-02 | 30-day Notice |
S017 | 2021-06-14 | 30-day Notice |
S016 | 2021-04-08 | 30-day Notice |
S015 | 2021-03-25 | 30-day Notice |
S014 | 2021-01-19 | 30-day Notice |
S013 | 2020-10-16 | 30-day Notice |
S012 | 2020-10-16 | 30-day Notice |
S011 | 2020-10-02 | Normal 180 Day Track No User Fee |
S010 | 2020-09-21 | 30-day Notice |
S009 | ||
S008 | 2020-07-22 | 30-day Notice |
S007 | ||
S006 | 2020-06-02 | 30-day Notice |
S005 | 2019-11-04 | 30-day Notice |
S004 | 2019-09-27 | 30-day Notice |
S003 | 2019-04-17 | Normal 180 Day Track No User Fee |
S002 | ||
S001 |