This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P120012S008 |
| Classification Name | None |
| Applicant | |
| PMA | P120012 |
| Supplement | S008 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120012 | Original Filing | |
| S019 | 2021-02-05 | 30-day Notice |
| S018 | 2019-04-10 | 30-day Notice |
| S017 | 2018-05-25 | 30-day Notice |
| S016 | 2017-06-27 | 135 Review Track For 30-day Notice |
| S015 | 2016-12-01 | 30-day Notice |
| S014 | 2016-06-01 | 30-day Notice |
| S013 | 2016-04-20 | 30-day Notice |
| S012 | 2016-03-28 | 30-day Notice |
| S011 | 2016-03-25 | 30-day Notice |
| S010 | 2015-12-16 | Real-time Process |
| S009 | 2015-07-29 | Real-time Process |
| S008 | ||
| S007 | 2015-03-26 | 30-day Notice |
| S006 | 2014-11-10 | 30-day Notice |
| S005 | 2014-10-24 | 30-day Notice |
| S004 | 2014-08-28 | 30-day Notice |
| S003 | 2013-07-23 | 30-day Notice |
| S002 | 2013-07-15 | 30-day Notice |
| S001 | 2013-07-12 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999036444 | P120012 | 001 |
| 00884999036147 | P120012 | 001 |
| 00884999036130 | P120012 | 001 |
| 00884999034266 | P120012 | 001 |
| 00884999042513 | P120012 | 010 |