N970012S077

None

FDA Premarket Approval N970012 S077

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

DeviceN970012S077
Classification NameNone
Applicant
PMAN970012
SupplementS077

Supplemental Filings

Supplement NumberDateSupplement Type
N970012Original Filing
S194 2022-11-01 30-day Notice
S193
S192 2022-08-19 30-day Notice
S191 2022-03-22 30-day Notice
S190 2022-03-15 30-day Notice
S189 2021-08-24 30-day Notice
S188 2021-06-11 30-day Notice
S187 2021-04-30 30-day Notice
S186
S185 2021-02-16 30-day Notice
S184 2020-12-03 30-day Notice
S183 2020-09-29 30-day Notice
S182 2020-08-17 30-day Notice
S181 2020-08-10 30-day Notice
S180 2020-08-07 30-day Notice
S179 2020-07-02 30-day Notice
S178 2020-05-18 30-day Notice
S177 2020-04-20 Normal 180 Day Track No User Fee
S176 2020-03-20 30-day Notice
S175 2020-02-10 30-day Notice
S174 2020-01-23 30-day Notice
S173 2019-11-14 30-day Notice
S172 2019-11-12 30-day Notice
S171 2019-11-12 30-day Notice
S170 2019-11-04 30-day Notice
S169 2019-10-31 30-day Notice
S168 2019-10-31 30-day Notice
S167 2019-08-22 30-day Notice
S166 2019-07-31 30-day Notice
S165 2019-06-14 30-day Notice
S164
S163
S162 2019-03-21 30-day Notice
S161 2019-03-12 Normal 180 Day Track No User Fee
S160
S159 2019-02-25 30-day Notice
S158
S157
S156 2019-01-18 30-day Notice
S155 2019-01-16 30-day Notice
S154
S153 2018-11-14 30-day Notice
S152 2018-10-23 30-day Notice
S151 2018-10-15 Real-time Process
S150 2018-09-28 Real-time Process
S149 2018-09-27 30-day Notice
S148 2018-08-21 30-day Notice
S147 2018-06-25 30-day Notice
S146 2018-06-19 135 Review Track For 30-day Notice
S145 2018-03-12 Special (immediate Track)
S144 2018-01-16 30-day Notice
S143 2018-01-08 30-day Notice
S142 2017-11-22 30-day Notice
S141 2017-11-22 30-day Notice
S140 2017-11-22 30-day Notice
S139 2017-09-27 Real-time Process
S138 2017-09-08 30-day Notice
S137 2017-07-17 30-day Notice
S136 2017-06-29 Real-time Process
S135 2017-05-17 Special (immediate Track)
S134 2017-04-12 30-day Notice
S133 2017-03-16 30-day Notice
S132 2017-03-15 30-day Notice
S131 2017-02-27 Real-time Process
S130 2017-02-21 30-day Notice
S129 2017-02-06 135 Review Track For 30-day Notice
S128 2017-01-30 Real-time Process
S127 2017-01-12 135 Review Track For 30-day Notice
S126 2016-12-27 135 Review Track For 30-day Notice
S125 2016-12-05 30-day Notice
S124 2016-11-29 30-day Notice
S123 2016-11-23 30-day Notice
S122 2016-11-21 30-day Notice
S121 2016-11-09 Real-time Process
S120 2016-11-04 30-day Notice
S119 2016-09-29 135 Review Track For 30-day Notice
S118 2016-09-19 Real-time Process
S117 2016-07-05 30-day Notice
S116 2016-06-06 30-day Notice
S115 2016-05-05 30-day Notice
S114 2016-04-22 135 Review Track For 30-day Notice
S113 2015-09-30 Special (immediate Track)
S112 2015-09-29 30-day Notice
S111 2015-09-18 135 Review Track For 30-day Notice
S110 2015-07-15 Special (immediate Track)
S109 2015-06-05 30-day Notice
S108 2015-04-08 30-day Notice
S107 2015-03-16 30-day Notice
S106 2015-03-16 30-day Notice
S105 2015-02-27 135 Review Track For 30-day Notice
S104 2015-01-12 30-day Notice
S103 2015-01-09 Real-time Process
S102 2014-11-03 Real-time Process
S101 2014-10-20 30-day Notice
S100 2014-10-09 30-day Notice
S099 2014-07-01 135 Review Track For 30-day Notice
S098 2013-12-05 30-day Notice
S097 2013-11-26 135 Review Track For 30-day Notice
S096 2013-07-16 Special (immediate Track)
S095 2012-12-06 30-day Notice
S094 2012-11-20 Real-time Process
S093 2012-09-10 30-day Notice
S092 2012-07-03 30-day Notice
S091
S090 2012-04-02 30-day Notice
S089 2011-09-28 30-day Notice
S088 2011-08-22 30-day Notice
S087 2011-07-29 30-day Notice
S086 2010-12-03 30-day Notice
S085 2010-11-26 30-day Notice
S084 2010-11-18 Special (immediate Track)
S083 2010-11-17 Normal 180 Day Track
S082 2010-11-17 30-day Notice
S081 2010-11-12 30-day Notice
S080
S079
S078 2010-07-27 30-day Notice
S077
S076
S075
S074
S073
S072
S071
S070
S069
S068
S067
S066
S065
S064
S063
S062
S061
S060
S059
S058
S057
S056
S055
S054
S053
S052
S051
S050
S049
S048
S047
S046
S045
S044
S043
S042
S041
S040
S039
S038
S037
S036
S035
S034
S033
S032
S031
S030
S029
S028
S027
S026
S025
S024
S023
S022
S021
S020
S019
S018
S017
S016
S015
S014
S013
S012
S011
S010
S009
S008
S007
S006
S005
S004
S003
S002
S001

NIH GUDID Devices

Device IDPMASupp
00878953003474 N970012 000
00878953003658 N970012 000
00878953003665 N970012 000
00878953003689 N970012 000
00878953003696 N970012 000
00878953003702 N970012 000
00878953003719 N970012 000
00878953003726 N970012 000
00878953003733 N970012 000
00878953003740 N970012 000
00878953003832 N970012 000
00878953003641 N970012 000
00878953003535 N970012 000
00878953003542 N970012 000
00878953003559 N970012 000
00878953003566 N970012 000
00878953003580 N970012 000
00878953003597 N970012 000
00878953003603 N970012 000
00878953003610 N970012 000
00878953003634 N970012 000
00878953003757 N970012 000
00878953003764 N970012 000
00878953003771 N970012 000
00878953003856 N970012 000
00878953005676 N970012 000
00878953001364 N970012 000
00878953005669 N970012 000
00878953003962 N970012 000
00878953003955 N970012 000
00878953003948 N970012 000
00878953003931 N970012 000
00878953003870 N970012 000
00878953003849 N970012 000
00878953003528 N970012 000
00878953003887 N970012 000
00878953003894 N970012 000
00878953003900 N970012 000
00878953003917 N970012 000
00878953003924 N970012 000
00878953003481 N970012 000
00878953003498 N970012 000
00878953003504 N970012 000
00878953003511 N970012 000
00878953003863 N970012 000
00878953005744 N970012 000
00878953003238 N970012 000
00878953001135 N970012 000
00878953005782 N970012 000
00878953005775 N970012 000
00878953005768 N970012 000
00878953005751 N970012 000
00878953003351 N970012 000
00878953005737 N970012 000
00878953005720 N970012 000
00878953003245 N970012 000
00878953003986 N970012 000
00878953000947 N970012 000
00878953000954 N970012 000
00878953000961 N970012 000
00878953000978 N970012 000
00878953000985 N970012 000
00878953000992 N970012 000
00878953001005 N970012 000
00878953001012 N970012 000
00878953001029 N970012 000
00878953005713 N970012 000
00878953003825 N970012 000
00878953003818 N970012 000
00878953003214 N970012 000
00878953003252 N970012 000
00878953003269 N970012 000
00878953003276 N970012 000
00878953003283 N970012 000
00878953003290 N970012 000
00878953003436 N970012 000
00878953003443 N970012 000
00878953003450 N970012 000
00878953003207 N970012 000
00878953002774 N970012 000
00878953003801 N970012 000
00878953003795 N970012 000
00878953003788 N970012 000
00878953002712 N970012 000
00878953002705 N970012 000
00878953002699 N970012 000
00878953002682 N970012 000
00878953002675 N970012 000
00878953002408 N970012 000
00878953003467 N970012 000
00878953009872 N970012 139
00878953009780 N970012 139
00878953009865 N970012 139
00878953009803 N970012 139
00878953009797 N970012 139
00878953009810 N970012 139
00878953009827 N970012 139
00878953009834 N970012 139
00878953009841 N970012 139
00878953009858 N970012 139
00191506021603 N970012 197
00191506021597 N970012 197
00191506021580 N970012 197
00191506021573 N970012 197
00191506021566 N970012 197
00191506021559 N970012 197
00191506021542 N970012 197
00191506021535 N970012 197
00191506021276 N970012 197
00191506021610 N970012 197
00191506021627 N970012 197
00191506021641 N970012 197
00191506021214 N970012 197
00191506021696 N970012 197
00191506021689 N970012 197
00191506021672 N970012 197
00191506021665 N970012 197
00191506021658 N970012 197
00191506021634 N970012 197
00191506021528 N970012 197
00191506021511 N970012 197
00191506021504 N970012 197
00191506021344 N970012 197
00191506021337 N970012 197
00191506021320 N970012 197
00191506021313 N970012 197
00191506021306 N970012 197
00191506021290 N970012 197
00191506021283 N970012 197
00191506021269 N970012 197
00191506021252 N970012 197
00191506021245 N970012 197
00191506021238 N970012 197
00191506021450 N970012 197
00191506021351 N970012 197
00191506021368 N970012 197
00191506021498 N970012 197
00191506021481 N970012 197
00191506021474 N970012 197
00191506021467 N970012 197
00191506021443 N970012 197
00191506021436 N970012 197
00191506021429 N970012 197
00191506021412 N970012 197
00191506021405 N970012 197
00191506021399 N970012 197
00191506021382 N970012 197
00191506021375 N970012 197
00191506021221 N970012 197

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