P100047S129

None

FDA Premarket Approval P100047 S129

This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.

Pre-market Approval Supplement Details

DeviceP100047S129
Classification NameNone
Applicant
PMAP100047
SupplementS129

Supplemental Filings

Supplement NumberDateSupplement Type
P100047Original Filing
S205 2023-01-19 30-day Notice
S204
S203
S202 2022-10-03 30-day Notice
S201 2022-05-31 30-day Notice
S200
S199 2022-05-25 30-day Notice
S198 2022-05-24 30-day Notice
S197 2022-04-18 30-day Notice
S196
S195 2022-02-15 Special (immediate Track)
S194 2022-02-15 30-day Notice
S193 2022-02-14 Special (immediate Track)
S192 2022-02-08 30-day Notice
S191 2021-10-28 30-day Notice
S190 2021-09-23 30-day Notice
S189 2021-07-19 Real-time Process
S188 2021-07-14 30-day Notice
S187
S186 2021-07-09 30-day Notice
S185 2021-06-24 30-day Notice
S184
S183
S182 2021-06-01 30-day Notice
S181 2021-05-28 30-day Notice
S180 2021-05-24 Special (immediate Track)
S179 2021-04-27 30-day Notice
S178
S177
S176 2021-03-01 Special (immediate Track)
S175 2021-02-10 30-day Notice
S174
S173
S172 2020-09-15 30-day Notice
S171 2020-08-31 30-day Notice
S170 2020-08-07 30-day Notice
S169
S168 2020-06-29 30-day Notice
S167 2020-06-19 30-day Notice
S166
S165
S164 2020-05-26 30-day Notice
S163
S162 2020-05-07 30-day Notice
S161 2020-04-10 30-day Notice
S160
S159
S158 2020-03-13 30-day Notice
S157 2020-03-09 30-day Notice
S156 2020-03-05 30-day Notice
S155
S154 2020-02-12 Real-time Process
S153 2020-02-04 30-day Notice
S152 2020-01-27 30-day Notice
S151
S150 2019-11-18 135 Review Track For 30-day Notice
S149
S148 2019-09-27 30-day Notice
S147 2019-09-25 30-day Notice
S146
S145 2019-08-08 30-day Notice
S144
S143 2019-07-26 30-day Notice
S142
S141 2019-06-10 30-day Notice
S140 2019-05-31 30-day Notice
S139
S138
S137 2019-03-04 30-day Notice
S136 2019-02-27 30-day Notice
S135 2019-02-19 Special (immediate Track)
S134
S133 2018-12-17 Normal 180 Day Track No User Fee
S132
S131
S130 2018-09-24 30-day Notice
S129
S128
S127 2018-08-24 30-day Notice
S126 2018-07-13 30-day Notice
S125 2018-06-14 30-day Notice
S124 2018-06-08 Normal 180 Day Track No User Fee
S123 2018-05-31 30-day Notice
S122 2018-05-10 Real-time Process
S121 2018-05-07 30-day Notice
S120 2018-05-02 135 Review Track For 30-day Notice
S119 2018-04-10 30-day Notice
S118 2018-03-15 Special (immediate Track)
S117 2018-01-29 30-day Notice
S116 2017-10-31 30-day Notice
S115 2017-10-30 Normal 180 Day Track No User Fee
S114 2017-10-30 Normal 180 Day Track No User Fee
S113 2017-10-26 30-day Notice
S112 2017-10-10 Normal 180 Day Track
S111 2017-09-28 Normal 180 Day Track
S110 2017-09-25 Normal 180 Day Track
S109 2017-08-28 30-day Notice
S108 2017-08-16 30-day Notice
S107 2017-08-14 30-day Notice
S106 2017-07-31 30-day Notice
S105 2017-07-27 30-day Notice
S104 2017-07-27 30-day Notice
S103 2017-07-20 30-day Notice
S102 2017-07-17 30-day Notice
S101 2017-06-20 Normal 180 Day Track
S100 2017-06-06 30-day Notice
S099 2017-06-05 30-day Notice
S098 2017-06-05 30-day Notice
S097 2017-05-30 30-day Notice
S096 2017-05-30 30-day Notice
S095 2017-05-30 30-day Notice
S094 2017-05-24 30-day Notice
S093 2017-05-22 30-day Notice
S092 2017-05-15 30-day Notice
S091 2017-02-14 30-day Notice
S090 2017-01-31 Panel Track
S089 2016-11-21 135 Review Track For 30-day Notice
S088 2016-11-18 30-day Notice
S087 2016-11-17 30-day Notice
S086 2016-10-31 30-day Notice
S085 2016-10-06 30-day Notice
S084 2016-10-05 30-day Notice
S083 2016-08-22 30-day Notice
S082 2016-08-19 Normal 180 Day Track
S081 2016-08-15 30-day Notice
S080 2016-08-11 30-day Notice
S079 2016-08-03 30-day Notice
S078 2016-07-25 30-day Notice
S077 2016-06-17 Normal 180 Day Track
S076 2016-05-25 30-day Notice
S075 2016-05-25 Special (immediate Track)
S074 2016-04-19 30-day Notice
S073 2016-02-22 30-day Notice
S072 2016-02-19 30-day Notice
S071 2015-12-28 30-day Notice
S070 2015-11-24 135 Review Track For 30-day Notice
S069 2015-11-20 30-day Notice
S068 2015-11-04 30-day Notice
S067 2015-10-22 30-day Notice
S066 2015-10-19 30-day Notice
S065 2015-07-28 30-day Notice
S064 2015-07-27 Normal 180 Day Track No User Fee
S063 2015-06-12 30-day Notice
S062 2015-06-03 30-day Notice
S061 2015-06-03 30-day Notice
S060 2015-06-03 30-day Notice
S059
S058
S057 2015-05-26 Normal 180 Day Track
S056 2015-02-26 30-day Notice
S055 2015-02-23 Special (immediate Track)
S054 2014-12-04 30-day Notice
S053 2014-11-13 Normal 180 Day Track
S052 2014-11-07 30-day Notice
S051 2014-11-03 30-day Notice
S050 2014-09-17 30-day Notice
S049 2014-08-11 Normal 180 Day Track
S048 2014-07-15 30-day Notice
S047 2014-06-16 Real-time Process
S046 2014-05-29 Normal 180 Day Track No User Fee
S045 2014-05-29 Normal 180 Day Track No User Fee
S044 2014-05-29 Special (immediate Track)
S043 2014-05-14 30-day Notice
S042 2014-05-13 30-day Notice
S041 2014-03-05 30-day Notice
S040 2014-02-26 Normal 180 Day Track
S039 2014-02-12 30-day Notice
S038 2014-02-11 30-day Notice
S037 2014-02-11 30-day Notice
S036 2014-01-22 30-day Notice
S035 2014-01-14 Normal 180 Day Track
S034 2014-01-10 30-day Notice
S033 2013-11-18 Real-time Process
S032 2013-12-06 Real-time Process
S031 2013-09-30 30-day Notice
S030 2013-09-17 30-day Notice
S029 2013-08-07 30-day Notice
S028 2013-07-05 30-day Notice
S027 2013-06-25 30-day Notice
S026 2013-06-17 Normal 180 Day Track No User Fee
S025 2013-06-17 Normal 180 Day Track No User Fee
S024 2013-06-17 Normal 180 Day Track No User Fee
S023 2013-06-03 Real-time Process
S022 2013-05-31 Special (immediate Track)
S021 2013-05-13 Normal 180 Day Track
S020 2013-05-01 Normal 180 Day Track
S019 2013-04-01 Real-time Process
S018 2013-03-04 30-day Notice
S017 2013-02-27 30-day Notice
S016
S015 2013-01-23 30-day Notice
S014 2012-12-20 Normal 180 Day Track No User Fee
S013 2012-12-05 135 Review Track For 30-day Notice
S012 2012-12-05 30-day Notice
S011 2012-12-05 30-day Notice
S010 2012-12-05 135 Review Track For 30-day Notice
S009 2012-12-03 30-day Notice
S008 2012-11-29 30-day Notice
S007 2012-11-30 30-day Notice
S006 2012-11-30 30-day Notice
S005 2012-11-29 135 Review Track For 30-day Notice
S004 2012-11-29 30-day Notice
S003 2012-11-27 30-day Notice
S002 2012-11-27 30-day Notice
S001 2012-11-27 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00888707007641 P100047 000
00888707009942 P100047 000
00888707010160 P100047 000
00888707010177 P100047 000
00888707007313 P100047 000
00888707009041 P100047 000
00888707005364 P100047 000
00888707005371 P100047 000
00888707005388 P100047 000
00888707005395 P100047 000
00888707009935 P100047 000
00888707009256 P100047 000
00888707007658 P100047 000
00888707008020 P100047 000
00888707008037 P100047 000
00888707008051 P100047 000
00888707008204 P100047 000
00888707008723 P100047 000
00888707008778 P100047 000
00888707008785 P100047 000
00888707009218 P100047 000
00888707007634 P100047 000
00888707006880 P100047 000
00888707002738 P100047 000
00888707002745 P100047 000
00888707003261 P100047 000
00888707005692 P100047 000
00888707005708 P100047 000
00888707006842 P100047 000
00888707006859 P100047 000
00888707006866 P100047 000
00888707006873 P100047 000
00888707002721 P100047 000
00888707002646 P100047 000
00888707002639 P100047 000
00888707006897 P100047 000
00888707000260 P100047 000
00888707000307 P100047 000
00888707000369 P100047 000
00888707000420 P100047 000
00888707000451 P100047 000
00888707000468 P100047 000
00888707000475 P100047 000
00888707001632 P100047 000
00763000629717 P100047 196

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