This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P010007S003 |
| Classification Name | None |
| Applicant | |
| PMA | P010007 |
| Supplement | S003 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010007 | Original Filing | |
| S017 | 2022-09-15 | 30-day Notice |
| S016 | ||
| S015 | 2022-02-28 | 30-day Notice |
| S014 | 2021-04-14 | 30-day Notice |
| S013 | 2020-08-12 | 30-day Notice |
| S012 | 2020-07-23 | 30-day Notice |
| S011 | 2019-11-25 | 30-day Notice |
| S010 | 2018-09-28 | Real-time Process |
| S009 | 2012-05-30 | 135 Review Track For 30-day Notice |
| S008 | 2011-12-19 | 135 Review Track For 30-day Notice |
| S007 | 2011-08-16 | 30-day Notice |
| S006 | 2011-08-08 | 30-day Notice |
| S005 | 2011-02-18 | Real-time Process |
| S004 | 2009-11-02 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2003-12-12 | Real-time Process |
| S001 | 2003-01-21 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414963594 | P010007 | 001 |
| 00630414961040 | P010007 | 001 |
| 00630414961033 | P010007 | 001 |
| 00630414953519 | P010007 | 001 |