This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P010030S162 |
| Classification Name | None |
| Applicant | |
| PMA | P010030 |
| Supplement | S162 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010030 | Original Filing | |
| S163 | 2023-01-09 | 30-day Notice |
| S162 | ||
| S161 | ||
| S160 | 2022-08-03 | 30-day Notice |
| S159 | 2022-05-17 | 30-day Notice |
| S158 | ||
| S157 | 2022-01-19 | 30-day Notice |
| S156 | 2021-11-30 | 30-day Notice |
| S155 | ||
| S154 | 2021-10-29 | 30-day Notice |
| S153 | 2021-10-01 | 30-day Notice |
| S152 | ||
| S151 | 2021-06-15 | Real-time Process |
| S150 | 2021-06-07 | Real-time Process |
| S149 | 2021-04-30 | 30-day Notice |
| S148 | 2021-04-30 | 30-day Notice |
| S147 | 2021-04-21 | 30-day Notice |
| S146 | 2020-10-29 | 30-day Notice |
| S145 | ||
| S144 | ||
| S143 | ||
| S142 | 2020-09-01 | 30-day Notice |
| S141 | ||
| S140 | 2020-06-22 | 30-day Notice |
| S139 | 2020-06-11 | 30-day Notice |
| S138 | ||
| S137 | 2020-05-04 | 30-day Notice |
| S136 | ||
| S135 | 2020-04-13 | 30-day Notice |
| S134 | 2020-04-01 | 30-day Notice |
| S133 | ||
| S132 | 2020-03-18 | 30-day Notice |
| S131 | 2019-12-19 | 30-day Notice |
| S130 | 2019-12-17 | 30-day Notice |
| S129 | 2019-12-03 | 30-day Notice |
| S128 | 2019-11-13 | 30-day Notice |
| S127 | ||
| S126 | 2019-09-30 | 30-day Notice |
| S125 | 2019-08-29 | 30-day Notice |
| S124 | ||
| S123 | 2019-08-07 | 30-day Notice |
| S122 | ||
| S121 | ||
| S120 | 2019-07-08 | 30-day Notice |
| S119 | 2019-06-27 | 30-day Notice |
| S118 | 2019-05-31 | 30-day Notice |
| S117 | 2019-05-15 | 30-day Notice |
| S116 | 2019-03-13 | 30-day Notice |
| S115 | 2019-02-13 | 30-day Notice |
| S114 | 2019-02-11 | 30-day Notice |
| S113 | 2019-02-07 | 30-day Notice |
| S112 | 2018-12-20 | 30-day Notice |
| S111 | 2018-12-10 | Real-time Process |
| S110 | 2018-10-01 | Real-time Process |
| S109 | ||
| S108 | 2018-08-08 | Special (immediate Track) |
| S107 | 2018-05-04 | 135 Review Track For 30-day Notice |
| S106 | 2018-05-03 | 135 Review Track For 30-day Notice |
| S105 | 2018-04-30 | 30-day Notice |
| S104 | 2018-04-24 | Real-time Process |
| S103 | 2017-11-13 | 30-day Notice |
| S102 | 2017-11-07 | Real-time Process |
| S101 | 2017-10-23 | 30-day Notice |
| S100 | 2017-10-20 | Normal 180 Day Track |
| S099 | 2017-08-24 | 30-day Notice |
| S098 | 2017-06-30 | Normal 180 Day Track |
| S097 | 2017-05-30 | Real-time Process |
| S096 | ||
| S095 | 2017-04-03 | 30-day Notice |
| S094 | ||
| S093 | ||
| S092 | 2017-02-07 | 30-day Notice |
| S091 | 2017-01-18 | Normal 180 Day Track |
| S090 | 2017-01-05 | Normal 180 Day Track |
| S089 | 2016-12-27 | 30-day Notice |
| S088 | 2016-12-23 | 30-day Notice |
| S087 | 2016-12-12 | Real-time Process |
| S086 | 2016-10-27 | Normal 180 Day Track No User Fee |
| S085 | 2016-10-04 | 30-day Notice |
| S084 | 2016-09-28 | Real-time Process |
| S083 | 2016-09-07 | 30-day Notice |
| S082 | ||
| S081 | 2016-08-31 | Real-time Process |
| S080 | 2016-08-11 | 30-day Notice |
| S079 | 2016-07-05 | 30-day Notice |
| S078 | 2016-06-23 | 30-day Notice |
| S077 | 2016-06-07 | 30-day Notice |
| S076 | 2016-05-20 | 30-day Notice |
| S075 | 2016-05-13 | 30-day Notice |
| S074 | 2016-04-19 | Real-time Process |
| S073 | 2016-03-16 | Real-time Process |
| S072 | 2016-01-27 | Real-time Process |
| S071 | 2015-11-23 | 30-day Notice |
| S070 | 2015-11-12 | Real-time Process |
| S069 | 2015-11-03 | 30-day Notice |
| S068 | 2015-10-16 | Real-time Process |
| S067 | 2015-10-02 | Normal 180 Day Track |
| S066 | 2015-09-03 | 30-day Notice |
| S065 | 2015-07-27 | 30-day Notice |
| S064 | 2015-07-02 | Real-time Process |
| S063 | 2015-06-29 | Real-time Process |
| S062 | 2015-06-04 | 30-day Notice |
| S061 | 2015-04-28 | 30-day Notice |
| S060 | 2015-02-27 | 30-day Notice |
| S059 | 2014-12-22 | Normal 180 Day Track |
| S058 | 2014-11-13 | Real-time Process |
| S057 | 2014-10-10 | 30-day Notice |
| S056 | 2013-02-19 | Panel Track |
| S055 | 2014-07-09 | 30-day Notice |
| S054 | 2014-07-11 | Real-time Process |
| S053 | 2014-05-27 | Real-time Process |
| S052 | 2014-05-21 | Real-time Process |
| S051 | 2014-05-12 | Real-time Process |
| S050 | 2014-05-08 | 30-day Notice |
| S049 | 2014-03-25 | Real-time Process |
| S048 | 2014-01-22 | 30-day Notice |
| S047 | 2013-12-23 | 30-day Notice |
| S046 | 2013-11-26 | 30-day Notice |
| S045 | 2013-11-21 | 30-day Notice |
| S044 | 2013-09-03 | 30-day Notice |
| S043 | ||
| S042 | 2013-02-12 | Normal 180 Day Track |
| S041 | 2013-02-12 | Real-time Process |
| S040 | 2013-02-05 | 135 Review Track For 30-day Notice |
| S039 | 2012-11-21 | Real-time Process |
| S038 | 2012-10-22 | 30-day Notice |
| S037 | 2012-10-18 | Real-time Process |
| S036 | 2012-09-19 | 30-day Notice |
| S035 | 2012-07-17 | Real-time Process |
| S034 | 2012-05-29 | Real-time Process |
| S033 | 2012-05-29 | 30-day Notice |
| S032 | 2012-05-14 | Real-time Process |
| S031 | 2011-10-20 | Normal 180 Day Track |
| S030 | 2011-09-27 | 30-day Notice |
| S029 | 2011-06-20 | Real-time Process |
| S028 | 2011-05-10 | |
| S027 | 2011-03-16 | Real-time Process |
| S026 | 2011-02-24 | 30-day Notice |
| S025 | 2011-01-03 | Real-time Process |
| S024 | 2010-09-07 | Real-time Process |
| S023 | 2010-08-17 | Normal 180 Day Track |
| S022 | 2010-08-03 | 30-day Notice |
| S021 | 2010-07-20 | Normal 180 Day Track No User Fee |
| S020 | 2010-05-06 | 30-day Notice |
| S019 | 2009-12-28 | Real-time Process |
| S018 | 2009-11-02 | Real-time Process |
| S017 | 2009-11-02 | 30-day Notice |
| S016 | 2009-11-02 | Real-time Process |
| S015 | 2009-10-30 | Real-time Process |
| S014 | 2009-10-30 | 30-day Notice |
| S013 | 2009-10-29 | Real-time Process |
| S012 | 2008-09-15 | Real-time Process |
| S011 | 2008-09-05 | Normal 180 Day Track |
| S010 | 2008-02-19 | Real-time Process |
| S009 | 2007-05-21 | Real-time Process |
| S008 | 2006-08-11 | Real-time Process |
| S007 | 2006-03-06 | Real-time Process |
| S006 | 2004-12-27 | Real-time Process |
| S005 | 2004-01-21 | Real-time Process |
| S004 | 2003-07-18 | Real-time Process |
| S003 | 2002-04-05 | Normal 180 Day Track |
| S002 | 2002-02-22 | Real-time Process |
| S001 | 2002-02-07 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00855778005043 | P010030 | 001 |
| 00855778005050 | P010030 | 001 |
| 00855778005029 | P010030 | 011 |
| 00855778005128 | P010030 | 011 |
| 00855778005012 | P010030 | 011 |
| 00855778005005 | P010030 | 011 |
| 00855778005036 | P010030 | 011 |
| 00855778005111 | P010030 | 025 |
| 00855778005135 | P010030 | 059 |
| 00855778005203 | P010030 | 067 |
| 00855778005159 | P010030 | 067 |
| 00855778005173 | P010030 | 067 |
| 00855778005180 | P010030 | 067 |
| 00855778005210 | P010030 | 098 |
| 00855778005432 | P010030 | 151 |
| 00855778005401 | P010030 | 162 |
| 00855778005388 | P010030 | 162 |
| 00855778005371 | P010030 | 162 |
| 00855778005395 | P010030 | 162 |
| 00855778005449 | P010030 | 164 |