This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P160045S021 |
| Classification Name | None |
| Applicant | |
| PMA | P160045 |
| Supplement | S021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160045 | Original Filing | |
| S038 | 2022-08-05 | Normal 180 Day Track No User Fee |
| S037 | 2022-06-14 | Real-time Process |
| S036 | 2022-03-29 | 135 Review Track For 30-day Notice |
| S035 | 2022-03-08 | Panel Track |
| S034 | 2021-12-23 | Normal 180 Day Track No User Fee |
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | 2021-05-14 | 30-day Notice |
| S029 | ||
| S028 | ||
| S027 | ||
| S026 | ||
| S025 | ||
| S024 | 2020-11-06 | 30-day Notice |
| S023 | 2020-10-01 | 30-day Notice |
| S022 | 2020-09-11 | 30-day Notice |
| S021 | ||
| S020 | 2020-05-14 | 30-day Notice |
| S019 | ||
| S018 | 2019-10-16 | 30-day Notice |
| S017 | ||
| S016 | 2019-07-22 | 30-day Notice |
| S015 | 2019-04-23 | 30-day Notice |
| S014 | 2019-01-31 | 30-day Notice |
| S013 | 2019-01-25 | 30-day Notice |
| S012 | 2018-11-13 | 30-day Notice |
| S011 | 2018-10-19 | 30-day Notice |
| S010 | 2018-10-09 | 30-day Notice |
| S009 | ||
| S008 | 2018-07-20 | 30-day Notice |
| S007 | ||
| S006 | 2018-05-02 | 30-day Notice |
| S005 | 2018-03-22 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2017-11-20 | 30-day Notice |
| S002 | 2017-11-08 | 30-day Notice |
| S001 | 2017-07-28 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 10190302015103 | P160045 | 000 |
| 10190302006156 | P160045 | 000 |
| 10190302006095 | P160045 | 000 |
| 10190302006064 | P160045 | 000 |
| 10190302015646 | P160045 | 000 |
| 10190302006071 | P160045 | 000 |
| 10190302017756 | P160045 | 000 |