This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P060019S048 |
| Classification Name | None |
| Applicant | |
| PMA | P060019 |
| Supplement | S048 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060019 | Original Filing | |
| S054 | 2021-09-14 | 30-day Notice |
| S053 | 2021-04-19 | 30-day Notice |
| S052 | 2021-04-13 | 30-day Notice |
| S051 | 2021-02-25 | 30-day Notice |
| S050 | 2021-01-13 | Real-time Process |
| S049 | 2020-09-18 | 30-day Notice |
| S048 | ||
| S047 | 2020-02-20 | Real-time Process |
| S046 | 2020-02-04 | 30-day Notice |
| S045 | 2019-03-15 | 30-day Notice |
| S044 | 2018-12-12 | Special (immediate Track) |
| S043 | ||
| S042 | 2018-02-05 | 30-day Notice |
| S041 | 2017-09-11 | Real-time Process |
| S040 | ||
| S039 | 2017-05-04 | 30-day Notice |
| S038 | 2016-08-12 | 30-day Notice |
| S037 | 2016-05-27 | 30-day Notice |
| S036 | 2016-02-19 | 30-day Notice |
| S035 | 2015-11-20 | Real-time Process |
| S034 | 2015-09-23 | 30-day Notice |
| S033 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S032 | 2015-05-15 | Normal 180 Day Track No User Fee |
| S031 | 2015-04-20 | 30-day Notice |
| S030 | 2014-11-07 | Real-time Process |
| S029 | 2014-09-09 | Real-time Process |
| S028 | 2014-04-30 | Normal 180 Day Track No User Fee |
| S027 | 2014-03-03 | Real-time Process |
| S026 | 2013-11-27 | Normal 180 Day Track |
| S025 | 2013-09-25 | Normal 180 Day Track |
| S024 | 2013-08-30 | 30-day Notice |
| S023 | 2012-07-11 | 135 Review Track For 30-day Notice |
| S022 | 2012-07-10 | Real-time Process |
| S021 | 2012-05-11 | Real-time Process |
| S020 | 2011-11-29 | 135 Review Track For 30-day Notice |
| S019 | 2011-10-14 | 30-day Notice |
| S018 | ||
| S017 | 2011-01-18 | 30-day Notice |
| S016 | 2010-11-30 | 30-day Notice |
| S015 | 2010-11-16 | Real-time Process |
| S014 | 2010-09-29 | 30-day Notice |
| S013 | 2010-08-30 | Normal 180 Day Track |
| S012 | ||
| S011 | 2010-02-22 | 30-day Notice |
| S010 | 2009-12-14 | 30-day Notice |
| S009 | 2009-05-14 | Normal 180 Day Track |
| S008 | 2009-05-04 | 30-day Notice |
| S007 | 2008-11-10 | 30-day Notice |
| S006 | ||
| S005 | 2008-07-14 | Normal 180 Day Track |
| S004 | 2008-04-14 | Real-time Process |
| S003 | 2007-06-07 | Real-time Process |
| S002 | 2007-05-31 | Real-time Process |
| S001 | 2007-03-30 | 135 Review Track For 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734309059 | P060019 | 000 |
| 05414734308595 | P060019 | 000 |
| 05414734308588 | P060019 | 000 |
| 05414734308571 | P060019 | 000 |
| 05414734308564 | P060019 | 000 |
| 05414734306737 | P060019 | 000 |
| 05414734306720 | P060019 | 000 |
| 05414734306713 | P060019 | 000 |
| 05414734306706 | P060019 | 000 |
| 05415067019875 | P060019 | 002 |
| 05414734309080 | P060019 | 005 |
| 05414734258616 | P060019 | 005 |
| 05415067008985 | P060019 | 005 |
| 05414734310765 | P060019 | 021 |
| 05414734310758 | P060019 | 021 |
| 05414734310741 | P060019 | 021 |
| 05414734310734 | P060019 | 021 |
| 05414734310680 | P060019 | 021 |
| 05414734310673 | P060019 | 021 |
| 05414734310666 | P060019 | 021 |
| 05414734310659 | P060019 | 021 |
| 05415067016669 | P060019 | 029 |