This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
Device | P010030S158 |
Classification Name | None |
Applicant | |
PMA | P010030 |
Supplement | S158 |
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 |
---|---|---|
00855778005050 | P010030 | 001 |
00855778005043 | P010030 | 001 |
00855778005005 | P010030 | 011 |
00855778005012 | P010030 | 011 |
00855778005029 | P010030 | 011 |
00855778005128 | 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 |