This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P160014S011 |
| Classification Name | None |
| Applicant | |
| PMA | P160014 |
| Supplement | S011 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160014 | Original Filing | |
| S018 | 2021-05-20 | Normal 180 Day Track No User Fee |
| S017 | 2020-10-20 | 30-day Notice |
| S016 | 2020-04-21 | 30-day Notice |
| S015 | ||
| S014 | 2019-09-12 | 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2019-02-22 | 30-day Notice |
| S007 | 2019-02-15 | 30-day Notice |
| S006 | 2018-10-23 | 135 Review Track For 30-day Notice |
| S005 | 2018-10-19 | Real-time Process |
| S004 | 2018-09-04 | 30-day Notice |
| S003 | 2018-08-16 | Real-time Process |
| S002 | 2018-06-12 | 30-day Notice |
| S001 | 2018-03-19 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00879397000944 | P160014 | 000 |
| 00879397000784 | P160014 | 000 |
| 00879397000777 | P160014 | 000 |
| 00879397000760 | P160014 | 000 |
| 00879397000753 | P160014 | 000 |
| 00879397000746 | P160014 | 000 |
| 00879397000739 | P160014 | 000 |
| 00879397000722 | P160014 | 000 |
| 00879397000715 | P160014 | 000 |
| 00879397000708 | P160014 | 000 |
| 00879397000692 | P160014 | 000 |
| 00879397000685 | P160014 | 000 |
| 00879397000678 | P160014 | 000 |
| 00879397000661 | P160014 | 000 |
| 00879397000791 | P160014 | 000 |
| 00879397000807 | P160014 | 000 |
| 00879397000937 | P160014 | 000 |
| 00879397000920 | P160014 | 000 |
| 00879397000913 | P160014 | 000 |
| 00879397000906 | P160014 | 000 |
| 00879397000890 | P160014 | 000 |
| 00879397000883 | P160014 | 000 |
| 00879397000876 | P160014 | 000 |
| 00879397000869 | P160014 | 000 |
| 00879397000852 | P160014 | 000 |
| 00879397000845 | P160014 | 000 |
| 00879397000838 | P160014 | 000 |
| 00879397000821 | P160014 | 000 |
| 00879397000814 | P160014 | 000 |
| 00879397000654 | P160014 | 000 |