P010032S121

None

FDA Premarket Approval P010032 S121

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

DeviceP010032S121
Classification NameNone
Applicant
PMAP010032
SupplementS121

Supplemental Filings

Supplement NumberDateSupplement Type
P010032Original Filing
S194 2022-09-29 30-day Notice
S193
S192
S191
S190 2022-08-11 30-day Notice
S189
S188 2022-06-02 30-day Notice
S187
S186
S185 2022-02-22 30-day Notice
S184 2022-01-18 30-day Notice
S183 2021-10-22 Real-time Process
S182 2021-10-05 30-day Notice
S181 2021-10-01 30-day Notice
S180
S179 2021-07-01 30-day Notice
S178
S177 2021-06-15 Special (immediate Track)
S176
S175 2021-05-10 30-day Notice
S174 2021-03-25 30-day Notice
S173
S172
S171
S170 2020-12-17 30-day Notice
S169
S168
S167 2020-07-27 Real-time Process
S166
S165
S164 2020-05-07 30-day Notice
S163 2020-04-30 30-day Notice
S162
S161 2020-04-06 30-day Notice
S160 2020-04-06 30-day Notice
S159 2020-02-03 30-day Notice
S158 2019-12-13 30-day Notice
S157
S156
S155 2019-10-21 30-day Notice
S154 2019-07-01 Real-time Process
S153 2019-07-01 30-day Notice
S152 2019-06-17 30-day Notice
S151
S150 2019-05-07 Normal 180 Day Track No User Fee
S149
S148 2019-01-23 Real-time Process
S147 2018-12-26 Real-time Process
S146 2018-12-17 30-day Notice
S145 2018-11-08 30-day Notice
S144 2018-10-19 30-day Notice
S143 2018-09-06 30-day Notice
S142
S141 2018-02-13 Normal 180 Day Track
S140 2017-12-18 30-day Notice
S139 2017-12-15 30-day Notice
S138 2017-11-16 30-day Notice
S137 2017-11-15 Real-time Process
S136 2017-11-13 30-day Notice
S135 2017-09-12 Normal 180 Day Track
S134 2017-09-11 Real-time Process
S133 2017-08-10 30-day Notice
S132 2017-07-28 Normal 180 Day Track No User Fee
S131
S130 2017-06-26 30-day Notice
S129 2017-06-02 30-day Notice
S128 2017-05-23 30-day Notice
S127 2016-11-07 Normal 180 Day Track
S126 2016-11-01 30-day Notice
S125 2016-10-24 Normal 180 Day Track
S124 2016-10-11 Real-time Process
S123
S122 2016-07-11 Real-time Process
S121
S120 2016-06-22 Real-time Process
S119 2016-06-13 30-day Notice
S118 2016-06-06 Normal 180 Day Track
S117 2016-04-28 30-day Notice
S116 2016-03-30 30-day Notice
S115 2016-03-21 Normal 180 Day Track
S114 2016-03-21 30-day Notice
S113 2016-02-02 30-day Notice
S112 2016-01-27 30-day Notice
S111 2016-01-19 30-day Notice
S110 2015-12-23 Real-time Process
S109 2015-12-11 Normal 180 Day Track
S108 2015-12-08 Real-time Process
S107 2015-11-09 30-day Notice
S106 2015-11-06 30-day Notice
S105 2015-10-08 30-day Notice
S104 2015-10-07 30-day Notice
S103 2015-10-06 30-day Notice
S102 2015-09-21 Real-time Process
S101 2015-09-15 30-day Notice
S100 2015-08-21 Normal 180 Day Track No User Fee
S099 2015-08-14 30-day Notice
S098 2015-08-04 Real-time Process
S097 2015-07-02 Normal 180 Day Track
S096 2015-04-02 Normal 180 Day Track
S095 2015-01-29 30-day Notice
S094 2014-12-24 Real-time Process
S093 2014-12-24 Normal 180 Day Track
S092 2014-12-19 Normal 180 Day Track
S091 2014-12-15 Normal 180 Day Track No User Fee
S090 2014-12-15 Real-time Process
S089 2014-11-21 30-day Notice
S088 2014-11-20 30-day Notice
S087 2014-11-18 Real-time Process
S086 2014-10-14 30-day Notice
S085 2014-09-29 Normal 180 Day Track
S084 2014-09-08 30-day Notice
S083 2014-07-10 Real-time Process
S082 2014-06-20 30-day Notice
S081 2014-06-11 Real-time Process
S080 2014-05-29 30-day Notice
S079 2014-04-15 Real-time Process
S078 2014-04-08 Real-time Process
S077 2014-03-06 30-day Notice
S076 2014-01-10 Real-time Process
S075 2014-01-03 Normal 180 Day Track
S074 2013-12-23 Real-time Process
S073 2013-07-29 Normal 180 Day Track No User Fee
S072 2013-06-14 30-day Notice
S071 2013-05-20 Real-time Process
S070 2013-03-11 30-day Notice
S069
S068 2013-02-19 Real-time Process
S067 2013-01-28 Real-time Process
S066 2012-12-26 Real-time Process
S065 2012-12-17 30-day Notice
S064 2012-11-07 30-day Notice
S063 2012-10-15 Normal 180 Day Track
S062 2012-08-03 30-day Notice
S061 2012-07-30 135 Review Track For 30-day Notice
S060 2012-07-20 30-day Notice
S059 2012-07-17 135 Review Track For 30-day Notice
S058 2012-07-16 Real-time Process
S057 2012-07-06 Real-time Process
S056 2012-07-02 30-day Notice
S055 2012-06-06 135 Review Track For 30-day Notice
S054 2012-06-01 Real-time Process
S053 2012-06-01 Real-time Process
S052 2012-05-31 30-day Notice
S051 2012-04-19 30-day Notice
S050 2012-04-18 135 Review Track For 30-day Notice
S049 2012-03-27 30-day Notice
S048 2012-02-15 Real-time Process
S047 2012-02-01 30-day Notice
S046
S045 2011-12-21 30-day Notice
S044 2011-12-09 30-day Notice
S043 2011-10-04 30-day Notice
S042
S041 2011-08-29 Real-time Process
S040 2011-07-18 Special (immediate Track)
S039 2011-06-20 135 Review Track For 30-day Notice
S038 2011-05-11 135 Review Track For 30-day Notice
S037 2010-12-29 Real-time Process
S036 2010-11-23 Real-time Process
S035 2010-10-21 Special (immediate Track)
S034 2010-10-20 Special (immediate Track)
S033
S032 2009-07-15 Real-time Process
S031 2009-07-01 Normal 180 Day Track
S030
S029 2009-04-02 Real-time Process
S028 2009-01-08 Normal 180 Day Track No User Fee
S027 2008-12-03 30-day Notice
S026 2008-06-10 Real-time Process
S025 2008-04-11 Real-time Process
S024 2008-01-22 Special (immediate Track)
S023 2007-10-02 Normal 180 Day Track
S022 2007-08-06 Real-time Process
S021 2007-07-13 Normal 180 Day Track
S020 2007-03-21 Real-time Process
S019 2006-01-23 Normal 180 Day Track
S018 2005-11-25 Real-time Process
S017 2005-08-30 Normal 180 Day Track
S016 2005-02-22 Real-time Process
S015
S014 2004-12-27 Real-time Process
S013 2004-12-16 Real-time Process
S012 2004-05-10 Normal 180 Day Track
S011 2004-04-09 Normal 180 Day Track No User Fee
S010 2004-03-24 Real-time Process
S009 2003-11-12 Real-time Process
S008 2003-05-28 Real-time Process
S007 2003-01-23 Normal 180 Day Track
S006 2002-11-04 Real-time Process
S005 2002-10-24 Real-time Process
S004
S003 2002-07-02 Real-time Process
S002 2002-05-14 Real-time Process
S001

NIH GUDID Devices

Device IDPMASupp
05415067019455 P010032 000
05414734406192 P010032 000
05415067017802 P010032 000
05415067019462 P010032 000
05415067017420 P010032 000
05415067019424 P010032 000
15414734400050 P010032 000
15414734400043 P010032 000
05414734401623 P010032 000
05415067017857 P010032 000
05415067017772 P010032 000
05415067017918 P010032 000
05414734401579 P010032 000
05414734401616 P010032 000
05414734406123 P010032 000
05414734406048 P010032 000
05415067017246 P010032 000
15414734400029 P010032 000
05415067017321 P010032 000
05415067017529 P010032 000
05415067017482 P010032 000
05414734406031 P010032 000
05415067019493 P010032 002
15414734400074 P010032 002
05415067018441 P010032 008
05414734406222 P010032 010
05415067017543 P010032 010
05415067017598 P010032 013
05414734402095 P010032 013
05414734406208 P010032 013
05415067018144 P010032 013
05415067017703 P010032 013
05415067017833 P010032 013
05414734406253 P010032 013
05414734402064 P010032 013
05414734406291 P010032 013
05414734402224 P010032 013
05414734402736 P010032 014
05415067019509 P010032 014
15414734400098 P010032 014
05414734402583 P010032 014
05415067017819 P010032 014
05415067017826 P010032 014
05414734401630 P010032 018
05414734406239 P010032 018
05414734402170 P010032 018
05414734402194 P010032 018
05414734402132 P010032 018
05414734401562 P010032 018
05414734406147 P010032 018
05415067017314 P010032 018
05414734406277 P010032 018
05415067017499 P010032 018
05414734401593 P010032 018
05415067017697 P010032 018
05415067017383 P010032 018
05415067017611 P010032 018
15414734400746 P010032 019
05415067017789 P010032 020
05414734406154 P010032 020
05415067017758 P010032 020
05414734401876 P010032 020
05414734401883 P010032 020
05414734406178 P010032 020
05415067017369 P010032 021
05415067019615 P010032 021
05415067019554 P010032 023
05414734403382 P010032 023
05415067017307 P010032 023
05414734406161 P010032 026
05415067017628 P010032 026
05414734406246 P010032 029
05414734405157 P010032 053
05414734405690 P010032 078
05415067020833 P010032 078
15415067030273 P010032 081
05415067017086 P010032 085
15415067024081 P010032 085
15415067024067 P010032 085
15415067024098 P010032 085
05415067016560 P010032 092
05415067018854 P010032 092
05415067018533 P010032 092
05415067016553 P010032 092
05415067017253 P010032 093
05415067023971 P010032 096
05415067017093 P010032 109
05414734405485 P010032 109
05415067028709 P010032 135
05415067031426 P010032 151
05415067031419 P010032 151
05415067034977 P010032 186
05415067040763 P010032 186
05415067045652 P010032 186
05415067045676 P010032 186
05415067040756 P010032 186
05415067040749 P010032 186
05415067045713 P010032 186
05415067034960 P010032 186
05415067046376 P010032 187
05415067046383 P010032 187
05415067046390 P010032 187
05415067046406 P010032 187
05415067047823 P010032 193
05415067047922 P010032 193
05415067051882 P010032 217
05415067051905 P010032 225
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