This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P160008S013 |
| Classification Name | None |
| Applicant | |
| PMA | P160008 |
| Supplement | S013 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160008 | Original Filing | |
| S021 | 2022-11-01 | 30-day Notice |
| S020 | 2022-08-29 | Real-time Process |
| S019 | 2022-03-28 | Real-time Process |
| S018 | ||
| S017 | ||
| S016 | 2021-05-20 | 30-day Notice |
| S015 | 2020-10-28 | 30-day Notice |
| S014 | 2020-09-24 | 30-day Notice |
| S013 | ||
| S012 | 2020-06-22 | 30-day Notice |
| S011 | ||
| S010 | 2020-02-13 | 30-day Notice |
| S009 | ||
| S008 | 2019-12-13 | 30-day Notice |
| S007 | 2019-10-31 | 30-day Notice |
| S006 | 2019-06-03 | 30-day Notice |
| S005 | 2019-02-01 | 30-day Notice |
| S004 | 2018-11-23 | Real-time Process |
| S003 | 2018-11-21 | 30-day Notice |
| S002 | 2018-10-02 | 30-day Notice |
| S001 | 2018-09-11 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 05060167120695 | P160008 | 004 |
| 05060167129773 | P160008 | 004 |
| 05060167129735 | P160008 | 004 |
| 05060167129711 | P160008 | 004 |
| 05060167128066 | P160008 | 004 |
| 05060167120916 | P160008 | 004 |
| 05060167120893 | P160008 | 004 |
| 05060167120886 | P160008 | 004 |
| 05060167120701 | P160008 | 004 |
| 05060167120671 | P160008 | 004 |
| 05060167120688 | P160008 | 004 |
| 05060167120718 | P160008 | 004 |
| 05060167128080 | P160008 | 004 |
| 05060167128042 | P160008 | 004 |
| 05060167120909 | P160008 | 004 |
| 05060167120862 | P160008 | 004 |
| 05060167120855 | P160008 | 004 |
| 05060167120725 | P160008 | 004 |
| M727PADPAK01 | P160008 | 008 |
| M727PADPAK02 | P160008 | 008 |
| 05060167124488 | P160008 | 008 |