This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P100027S028 |
| Classification Name | None |
| Applicant | |
| PMA | P100027 |
| Supplement | S028 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100027 | Original Filing | |
| S038 | 2022-10-14 | 30-day Notice |
| S037 | 2022-07-12 | 30-day Notice |
| S036 | 2022-02-16 | Special (immediate Track) |
| S035 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S034 | 2021-02-22 | Real-time Process |
| S033 | 2020-08-26 | Real-time Process |
| S032 | 2020-01-13 | Real-time Process |
| S031 | 2019-08-22 | Real-time Process |
| S030 | 2019-02-13 | Normal 180 Day Track |
| S029 | 2018-06-18 | Real-time Process |
| S028 | ||
| S027 | 2017-07-17 | 30-day Notice |
| S026 | 2016-11-15 | Normal 180 Day Track |
| S025 | 2016-11-04 | 30-day Notice |
| S024 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S023 | 2015-08-26 | 30-day Notice |
| S022 | 2015-08-14 | 30-day Notice |
| S021 | 2015-02-11 | 30-day Notice |
| S020 | 2014-10-27 | 30-day Notice |
| S019 | 2014-06-16 | 135 Review Track For 30-day Notice |
| S018 | 2014-05-01 | Real-time Process |
| S017 | 2014-02-06 | Real-time Process |
| S016 | 2014-01-22 | Real-time Process |
| S015 | 2014-01-06 | 30-day Notice |
| S014 | 2013-12-27 | 30-day Notice |
| S013 | 2013-11-12 | 30-day Notice |
| S012 | 2013-10-28 | 30-day Notice |
| S011 | 2013-09-12 | 30-day Notice |
| S010 | 2013-05-07 | 30-day Notice |
| S009 | 2013-05-06 | Real-time Process |
| S008 | 2013-04-17 | 30-day Notice |
| S007 | 2013-03-12 | Real-time Process |
| S006 | 2013-03-04 | 30-day Notice |
| S005 | 2012-10-10 | Normal 180 Day Track |
| S004 | 2012-09-26 | Real-time Process |
| S003 | 2012-08-31 | Real-time Process |
| S002 | 2011-09-19 | Normal 180 Day Track |
| S001 | 2011-08-29 | Real-time Process |