This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P100016S009 |
| Classification Name | None |
| Applicant | |
| PMA | P100016 |
| Supplement | S009 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100016 | Original Filing | |
| S015 | 2022-12-09 | 30-day Notice |
| S014 | 2022-04-26 | 30-day Notice |
| S013 | 2022-03-25 | 30-day Notice |
| S012 | 2022-03-03 | 30-day Notice |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2020-09-08 | Normal 180 Day Track |
| S007 | 2020-08-31 | 135 Review Track For 30-day Notice |
| S006 | 2018-08-24 | 30-day Notice |
| S005 | 2018-02-08 | 30-day Notice |
| S004 | 2017-05-22 | Normal 180 Day Track No User Fee |
| S003 | 2017-03-24 | Special (immediate Track) |
| S002 | 2014-12-18 | Normal 180 Day Track No User Fee |
| S001 | 2013-02-19 | Normal 180 Day Track No User Fee |