This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P000027S003 |
| Classification Name | None |
| Applicant | |
| PMA | P000027 |
| Supplement | S003 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000027 | Original Filing | |
| S036 | 2021-10-18 | 30-day Notice |
| S035 | 2019-11-27 | Normal 180 Day Track |
| S034 | 2019-01-29 | Real-time Process |
| S033 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S032 | 2018-10-01 | 30-day Notice |
| S031 | 2018-04-17 | Real-time Process |
| S030 | 2018-03-01 | Real-time Process |
| S029 | ||
| S028 | 2017-10-11 | Real-time Process |
| S027 | 2017-08-28 | Normal 180 Day Track |
| S026 | 2017-08-03 | 30-day Notice |
| S025 | 2017-05-24 | 30-day Notice |
| S024 | 2016-10-26 | 30-day Notice |
| S023 | 2016-09-07 | Normal 180 Day Track No User Fee |
| S022 | 2016-02-18 | 30-day Notice |
| S021 | 2015-10-07 | 30-day Notice |
| S020 | 2014-11-25 | 30-day Notice |
| S019 | 2014-04-04 | Real-time Process |
| S018 | 2013-04-09 | Real-time Process |
| S017 | 2012-12-19 | 135 Review Track For 30-day Notice |
| S016 | ||
| S015 | 2012-02-29 | 30-day Notice |
| S014 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S013 | 2011-11-22 | 30-day Notice |
| S012 | 2011-08-01 | Normal 180 Day Track |
| S011 | 2011-05-03 | Normal 180 Day Track No User Fee |
| S010 | 2011-04-25 | 30-day Notice |
| S009 | 2011-04-11 | 135 Review Track For 30-day Notice |
| S008 | 2010-05-27 | 30-day Notice |
| S007 | 2008-09-02 | 30-day Notice |
| S006 | 2008-03-28 | Normal 180 Day Track |
| S005 | 2007-07-23 | Normal 180 Day Track |
| S004 | 2006-12-22 | 30-day Notice |
| S003 | ||
| S002 | 2002-10-11 | Normal 180 Day Track |
| S001 | 2001-11-07 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 04015630919338 | P000027 | 000 |
| 04015630919321 | P000027 | 000 |
| 04015630997053 | P000027 | 000 |
| 04015630919321 | P000027 | 023 |
| 04015630919338 | P000027 | 023 |
| 04015630997053 | P000027 | 023 |
| 04015630940011 | P000027 | 027 |
| 07613336166673 | P000027 | 035 |
| 07613336166628 | P000027 | 035 |
| 07613336168134 | P000027 | 035 |
| 07613336217672 | P000027 | 040 |