This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P050010S004 |
| Classification Name | None |
| Applicant | |
| PMA | P050010 |
| Supplement | S004 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050010 | Original Filing | |
| S023 | 2021-03-01 | 30-day Notice |
| S022 | 2019-09-09 | Real-time Process |
| S021 | ||
| S020 | ||
| S019 | 2017-10-18 | 30-day Notice |
| S018 | ||
| S017 | 2016-01-15 | 30-day Notice |
| S016 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S015 | ||
| S014 | 2012-12-07 | Normal 180 Day Track |
| S013 | 2012-11-08 | Normal 180 Day Track No User Fee |
| S012 | 2011-04-26 | Real-time Process |
| S011 | 2011-01-28 | 135 Review Track For 30-day Notice |
| S010 | 2010-09-29 | 135 Review Track For 30-day Notice |
| S009 | 2010-09-15 | 135 Review Track For 30-day Notice |
| S008 | 2010-08-02 | Real-time Process |
| S007 | 2010-05-19 | Normal 180 Day Track No User Fee |
| S006 | 2010-04-26 | 30-day Notice |
| S005 | 2010-04-26 | 30-day Notice |
| S004 | ||
| S003 | 2008-07-28 | 30-day Notice |
| S002 | 2008-05-29 | 135 Review Track For 30-day Notice |
| S001 | 2007-12-26 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 10705034700182 | P050010 | 000 |
| H981PDLMIP00S0D | P050010 | 000 |
| H981PDLLSP11S0O | P050010 | 000 |
| H981PDLLSP06S0S | P050010 | 000 |
| H981PDLLPT14S0S | P050010 | 000 |
| H981PDLLPT12S0Q | P050010 | 000 |
| H981PDLLPT10S0O | P050010 | 000 |
| H981PDLLIP00S0C | P050010 | 000 |
| 00843193114983 | P050010 | 000 |
| 00843193114976 | P050010 | 000 |
| 00843193114969 | P050010 | 000 |
| 00843193114952 | P050010 | 000 |
| 00843193114945 | P050010 | 000 |
| 00843193114938 | P050010 | 000 |
| H981PDLMPT10S0P | P050010 | 000 |
| H981PDLMPT12S0R | P050010 | 000 |
| 10705034700175 | P050010 | 000 |
| 10705034700151 | P050010 | 000 |
| 10705034700144 | P050010 | 000 |
| 10705034700137 | P050010 | 000 |
| 10705034700106 | P050010 | 000 |
| 10705034700090 | P050010 | 000 |
| 10705034700083 | P050010 | 000 |
| 10705034700069 | P050010 | 000 |
| 10705034700052 | P050010 | 000 |
| 10705034700045 | P050010 | 000 |
| H981PDLMSP11S0P | P050010 | 000 |
| H981PDLMSP06S0T | P050010 | 000 |
| H981PDLMPT14S0T | P050010 | 000 |
| 00843193111692 | P050010 | 000 |