This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P160048S018 |
| Classification Name | None |
| Applicant | |
| PMA | P160048 |
| Supplement | S018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160048 | Original Filing | |
| S017 | 2020-11-12 | 30-day Notice |
| S016 | ||
| S015 | ||
| S014 | 2019-08-27 | Normal 180 Day Track No User Fee |
| S013 | 2019-07-31 | 30-day Notice |
| S012 | ||
| S011 | 2019-06-27 | Normal 180 Day Track |
| S010 | 2019-06-24 | 30-day Notice |
| S009 | 2019-05-28 | 30-day Notice |
| S008 | 2018-12-11 | Real-time Process |
| S007 | 2018-11-28 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2018-09-11 | Real-time Process |
| S004 | 2018-09-07 | Real-time Process |
| S003 | 2018-08-27 | Normal 180 Day Track No User Fee |
| S002 | 2018-08-07 | Normal 180 Day Track |
| S001 | 2018-07-20 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00817491021908 | P160048 | 000 |
| 00817491022493 | P160048 | 000 |
| 00817491020819 | P160048 | 000 |
| 00817491020826 | P160048 | 000 |
| 00817491021328 | P160048 | 000 |
| 00817491021304 | P160048 | 000 |
| 00817491021311 | P160048 | 000 |
| 00817491021335 | P160048 | 000 |
| 00817491021397 | P160048 | 000 |
| 00817491021403 | P160048 | 000 |
| 00817491021410 | P160048 | 000 |
| 00817491021427 | P160048 | 000 |
| 00817491021434 | P160048 | 000 |
| 00817491021441 | P160048 | 000 |
| 00817491021458 | P160048 | 000 |
| 00817491022516 | P160048 | 006 |
| 00817491022523 | P160048 | 006 |
| 00817491022370 | P160048 | 006 |
| 00817491022387 | P160048 | 006 |
| 00817491022363 | P160048 | 008 |
| 00817491022356 | P160048 | 008 |
| 00817491022349 | P160048 | 008 |
| 00817491022936 | P160048 | 016 |
| 00817491022929 | P160048 | 016 |
| 00817491022912 | P160048 | 016 |
| 00817491022905 | P160048 | 016 |
| 00817491022950 | P160048 | 016 |
| 00817491022967 | P160048 | 016 |
| 00817491022974 | P160048 | 016 |
| 00817491021342 | P160048 | 016 |
| 00817491023063 | P160048 | 016 |
| 00817491023520 | P160048 | 016 |
| 00817491023537 | P160048 | 016 |
| 00817491022882 | P160048 | 016 |