This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P160037S012 |
| Classification Name | None |
| Applicant | |
| PMA | P160037 |
| Supplement | S012 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160037 | Original Filing | |
| S013 | 2022-11-21 | 30-day Notice |
| S012 | ||
| S011 | 2022-10-21 | 30-day Notice |
| S010 | 2021-10-28 | Real-time Process |
| S009 | 2020-09-14 | 30-day Notice |
| S008 | ||
| S007 | 2020-07-06 | 30-day Notice |
| S006 | 2020-02-21 | 30-day Notice |
| S005 | ||
| S004 | ||
| S003 | 2019-08-21 | Normal 180 Day Track No User Fee |
| S002 | 2019-02-26 | Real-time Process |
| S001 | 2018-04-27 | 135 Review Track For 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00382904440893 | P160037 | 000 |
| 00382904419905 | P160037 | 000 |
| 00382904440886 | P160037 | 000 |
| 00382904429577 | P160037 | 000 |
| 00382904429676 | P160037 | 000 |
| 00382904438371 | P160037 | 000 |
| 00382904440879 | P160037 | 000 |
| 00382904440725 | P160037 | 005 |
| 00382904440749 | P160037 | 005 |
| 00382904439903 | P160037 | 005 |
| 00382904439880 | P160037 | 005 |
| 00382904440831 | P160037 | 005 |
| 00382904440756 | P160037 | 005 |
| 00382904453282 | P160037 | 008 |
| 00382904453299 | P160037 | 008 |
| 00382904454364 | P160037 | 017 |
| 00382904454166 | P160037 | 017 |