This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P850064S004 |
| Classification Name | None |
| Applicant | |
| PMA | P850064 |
| Supplement | S004 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850064 | Original Filing | |
| S047 | 2022-03-07 | 30-day Notice |
| S046 | 2021-05-27 | 30-day Notice |
| S045 | ||
| S044 | 2021-01-28 | 30-day Notice |
| S043 | 2020-10-29 | 30-day Notice |
| S042 | 2019-11-15 | 30-day Notice |
| S041 | 2019-10-24 | 30-day Notice |
| S040 | ||
| S039 | 2019-02-27 | 135 Review Track For 30-day Notice |
| S038 | 2018-10-25 | 30-day Notice |
| S037 | 2018-09-20 | 30-day Notice |
| S036 | 2018-01-29 | Real-time Process |
| S035 | 2017-10-02 | Real-time Process |
| S034 | 2017-06-07 | 30-day Notice |
| S033 | 2016-07-22 | 30-day Notice |
| S032 | 2016-05-24 | Real-time Process |
| S031 | 2016-02-24 | Real-time Process |
| S030 | 2015-03-31 | Normal 180 Day Track |
| S029 | 2015-02-18 | 30-day Notice |
| S028 | 2015-02-04 | Normal 180 Day Track |
| S027 | 2014-08-25 | Normal 180 Day Track No User Fee |
| S026 | 2014-01-27 | 30-day Notice |
| S025 | 2013-09-09 | 30-day Notice |
| S024 | ||
| S023 | 2013-06-10 | Normal 180 Day Track |
| S022 | ||
| S021 | 2012-09-07 | Normal 180 Day Track |
| S020 | ||
| S019 | ||
| S018 | 2010-02-22 | Normal 180 Day Track |
| S017 | 2001-04-04 | Normal 180 Day Track |
| S016 | 1999-09-10 | Special (immediate Track) |
| S015 | 1998-10-21 | Normal 180 Day Track |
| S014 | 1998-08-28 | Special (immediate Track) |
| S013 | ||
| S012 | 1997-04-11 | Special (immediate Track) |
| S011 | 1995-04-05 | Normal 180 Day Track |
| S010 | 1994-08-05 | Normal 180 Day Track |
| S009 | 1992-11-27 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 1991-08-01 | Normal 180 Day Track |
| S005 | 1990-10-01 | Normal 180 Day Track |
| S004 | ||
| S003 | 1989-07-24 | Normal 180 Day Track |
| S002 | 1989-02-09 | Normal 180 Day Track |
| S001 | 1988-09-19 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 10616120000089 | P850064 | 000 |
| 00616120000020 | P850064 | 000 |
| 00616120000006 | P850064 | 000 |
| 00616120000013 | P850064 | 017 |
| 00616120000112 | P850064 | 028 |
| 00616120000105 | P850064 | 028 |