This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P040042S019 |
| Classification Name | None |
| Applicant | |
| PMA | P040042 |
| Supplement | S019 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040042 | Original Filing | |
| S054 | 2022-11-14 | 30-day Notice |
| S053 | ||
| S052 | 2022-10-19 | Normal 180 Day Track No User Fee |
| S051 | 2021-09-14 | 30-day Notice |
| S050 | 2021-04-13 | 30-day Notice |
| S049 | 2021-02-25 | 30-day Notice |
| S048 | 2021-01-13 | Real-time Process |
| S047 | 2020-09-18 | 30-day Notice |
| S046 | ||
| S045 | 2020-02-20 | Real-time Process |
| S044 | 2020-02-04 | 30-day Notice |
| S043 | 2019-07-29 | 30-day Notice |
| S042 | 2019-03-15 | 30-day Notice |
| S041 | 2018-12-12 | Special (immediate Track) |
| S040 | 2018-02-05 | 30-day Notice |
| S039 | ||
| S038 | ||
| S037 | 2017-05-04 | 30-day Notice |
| S036 | 2016-08-12 | 30-day Notice |
| S035 | 2016-05-27 | 30-day Notice |
| S034 | 2016-02-19 | 30-day Notice |
| S033 | 2015-11-20 | Real-time Process |
| S032 | 2015-09-23 | 30-day Notice |
| S031 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S030 | 2015-04-20 | 30-day Notice |
| S029 | 2014-11-07 | 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 | 2013-08-30 | 30-day Notice |
| S024 | 2011-11-29 | 135 Review Track For 30-day Notice |
| S023 | 2011-10-14 | 30-day Notice |
| S022 | 2011-05-09 | 30-day Notice |
| S021 | 2011-01-18 | 30-day Notice |
| S020 | 2010-11-16 | Real-time Process |
| S019 | ||
| S018 | 2010-02-22 | 30-day Notice |
| S017 | 2009-12-14 | 30-day Notice |
| S016 | 2009-07-30 | 30-day Notice |
| S015 | 2009-05-04 | 30-day Notice |
| S014 | 2008-11-10 | 30-day Notice |
| S013 | 2008-09-04 | Normal 180 Day Track |
| S012 | 2008-05-14 | 30-day Notice |
| S011 | 2007-09-19 | 30-day Notice |
| S010 | 2007-03-16 | 30-day Notice |
| S009 | 2007-03-12 | Normal 180 Day Track |
| S008 | 2007-02-12 | Real-time Process |
| S007 | 2006-12-18 | 135 Review Track For 30-day Notice |
| S006 | 2006-09-05 | Normal 180 Day Track |
| S005 | 2006-08-18 | Real-time Process |
| S004 | 2006-08-01 | Real-time Process |
| S003 | 2006-06-02 | Real-time Process |
| S002 | 2006-05-01 | Real-time Process |
| S001 | 2005-11-22 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734306980 | P040042 | 000 |
| 05414734306973 | P040042 | 000 |
| 05414734306997 | P040042 | 000 |
| 05414734307000 | P040042 | 000 |
| 05414734307024 | P040042 | 000 |
| 05414734307017 | P040042 | 000 |
| 05414734308939 | P040042 | 005 |
| 05414734309073 | P040042 | 006 |
| 05414734307550 | P040042 | 006 |
| 05414734307567 | P040042 | 006 |
| 05414734307581 | P040042 | 006 |
| 05414734307598 | P040042 | 006 |
| 05414734300162 | P040042 | 009 |
| 05414734300179 | P040042 | 009 |
| 05414734300186 | P040042 | 009 |
| 05414734300193 | P040042 | 009 |
| 05414734300247 | P040042 | 009 |
| 05414734300254 | P040042 | 009 |
| 05414734300261 | P040042 | 009 |
| 05414734300278 | P040042 | 009 |
| 05414734300155 | P040042 | 009 |