This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P160042S013 |
| Classification Name | None |
| Applicant | |
| PMA | P160042 |
| Supplement | S013 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160042 | Original Filing | |
| S017 | 2021-10-05 | 135 Review Track For 30-day Notice |
| S016 | ||
| S015 | 2021-03-17 | Special (immediate Track) |
| S014 | ||
| S013 | ||
| S012 | 2020-07-15 | Real-time Process |
| S011 | 2020-01-22 | Real-time Process |
| S010 | ||
| S009 | 2019-05-06 | 30-day Notice |
| S008 | ||
| S007 | ||
| S006 | ||
| S005 | ||
| S004 | 2018-05-29 | Normal 180 Day Track |
| S003 | 2017-12-20 | Normal 180 Day Track |
| S002 | ||
| S001 | 2017-08-14 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 66980800001000 | P160042 | 000 |
| 66980800001017 | P160042 | 003 |
| 66980800001024 | P160042 | 004 |
| 10669808003032 | P160042 | 014 |