This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P010053S002 |
| Classification Name | None |
| Applicant | |
| PMA | P010053 |
| Supplement | S002 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010053 | Original Filing | |
| S016 | 2022-09-15 | 30-day Notice |
| S015 | ||
| S014 | 2022-02-28 | 30-day Notice |
| S013 | 2020-12-22 | Real-time Process |
| S012 | 2020-08-12 | 30-day Notice |
| S011 | 2019-11-25 | 30-day Notice |
| S010 | 2011-12-19 | 135 Review Track For 30-day Notice |
| S009 | 2011-08-16 | 30-day Notice |
| S008 | 2011-08-08 | 30-day Notice |
| S007 | 2011-02-18 | Real-time Process |
| S006 | 2009-11-02 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2008-11-10 | Normal 180 Day Track No User Fee |
| S003 | 2005-08-17 | Special (immediate Track) |
| S002 | ||
| S001 | 2002-11-20 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414977737 | P010053 | 001 |
| 00630414977720 | P010053 | 001 |
| 00630414960975 | P010053 | 001 |