P080025S179

None

FDA Premarket Approval P080025 S179

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

DeviceP080025S179
Classification NameNone
Applicant
PMAP080025
SupplementS179

Supplemental Filings

Supplement NumberDateSupplement Type
P080025Original Filing
S196 2019-09-16 30-day Notice
S195 2019-09-12 Special (immediate Track)
S194
S193 2019-08-29 30-day Notice
S192 2019-08-19 30-day Notice
S191 2019-07-29 30-day Notice
S190 2019-07-16 30-day Notice
S189
S188 2019-06-26 Special (immediate Track)
S187
S186 2019-06-06 30-day Notice
S185 2019-05-06 30-day Notice
S184 2019-04-26 30-day Notice
S183 2019-04-24 30-day Notice
S182 2019-04-17 30-day Notice
S181 2019-04-01 30-day Notice
S180 2019-03-07 30-day Notice
S179
S178 2019-02-21 30-day Notice
S177 2018-12-26 Real-time Process
S176 2018-12-11 30-day Notice
S175 2018-11-06 30-day Notice
S174 2018-10-19 30-day Notice
S173 2018-09-10 30-day Notice
S172 2018-08-02 30-day Notice
S171 2018-07-17 30-day Notice
S170 2018-06-18 30-day Notice
S169 2018-05-18 30-day Notice
S168 2018-05-16 30-day Notice
S167 2018-05-07 30-day Notice
S166 2018-05-02 30-day Notice
S165 2018-04-26 30-day Notice
S164 2018-04-16 30-day Notice
S163 2018-04-04 Normal 180 Day Track
S162 2018-03-14 30-day Notice
S161 2018-03-12 30-day Notice
S160 2018-01-05 135 Review Track For 30-day Notice
S159 2017-11-20 30-day Notice
S158
S157 2017-11-13 30-day Notice
S156 2017-11-08 Real-time Process
S155 2017-10-20 30-day Notice
S154 2017-10-10 30-day Notice
S153 2017-09-27 30-day Notice
S152 2017-09-13 30-day Notice
S151 2017-09-05 Normal 180 Day Track No User Fee
S150 2017-08-28 30-day Notice
S149 2017-08-22 135 Review Track For 30-day Notice
S148 2017-08-21 Normal 180 Day Track No User Fee
S147 2017-08-03 135 Review Track For 30-day Notice
S146 2017-07-27 30-day Notice
S145 2017-07-17 30-day Notice
S144 2017-07-17 Real-time Process
S143 2017-07-17 30-day Notice
S142 2017-06-27 Normal 180 Day Track
S141 2017-06-16 30-day Notice
S140 2017-05-18 30-day Notice
S139 2017-05-12 30-day Notice
S138 2017-05-03 30-day Notice
S137 2017-04-28 30-day Notice
S136 2017-04-26 30-day Notice
S135 2017-04-03 30-day Notice
S134 2017-03-29 30-day Notice
S133 2017-03-09 30-day Notice
S132 2017-01-13 30-day Notice
S131 2017-01-11 30-day Notice
S130 2017-01-09 30-day Notice
S129 2016-12-19 30-day Notice
S128 2016-11-23 30-day Notice
S127 2016-11-21 30-day Notice
S126 2016-11-14 30-day Notice
S125 2016-10-18 30-day Notice
S124 2016-09-28 30-day Notice
S123 2016-08-25 Real-time Process
S122 2016-08-15 30-day Notice
S121 2016-08-15 30-day Notice
S120 2016-08-15 Real-time Process
S119 2016-08-12 30-day Notice
S118 2016-08-01 30-day Notice
S117 2016-07-25 30-day Notice
S116 2016-07-08 Special (immediate Track)
S115 2016-06-27 30-day Notice
S114 2016-06-27 30-day Notice
S113 2016-06-21 Normal 180 Day Track No User Fee
S112 2016-06-16 30-day Notice
S111 2016-06-09 30-day Notice
S110 2016-06-07 30-day Notice
S109 2016-06-06 30-day Notice
S108 2016-05-12 30-day Notice
S107 2016-04-05 30-day Notice
S106 2016-03-04 30-day Notice
S105 2016-02-08 Normal 180 Day Track
S104 2015-12-28 30-day Notice
S103 2015-11-23 30-day Notice
S102 2015-10-29 30-day Notice
S101 2015-10-13 30-day Notice
S100 2015-09-30 30-day Notice
S099 2015-08-31 135 Review Track For 30-day Notice
S098 2015-08-13 30-day Notice
S097 2015-06-17 30-day Notice
S096 2015-06-16 30-day Notice
S095 2015-06-11 30-day Notice
S094 2015-06-01 30-day Notice
S093 2015-04-28 30-day Notice
S092 2015-04-20 Normal 180 Day Track No User Fee
S091 2015-03-19 30-day Notice
S090 2015-03-06 30-day Notice
S089 2015-03-03 30-day Notice
S088 2015-02-27 30-day Notice
S087 2015-02-27 30-day Notice
S086 2015-02-04 30-day Notice
S085 2015-01-12 30-day Notice
S084 2015-01-09 30-day Notice
S083 2014-12-29 Normal 180 Day Track
S082 2014-11-24 30-day Notice
S081 2014-09-16 30-day Notice
S080 2014-09-04 30-day Notice
S079 2014-08-25 30-day Notice
S078 2014-08-01 30-day Notice
S077 2014-07-30 30-day Notice
S076 2014-07-03 30-day Notice
S075 2014-06-30 30-day Notice
S074 2014-06-27 Special (immediate Track)
S073 2014-06-04 30-day Notice
S072 2014-06-02 30-day Notice
S071 2014-05-30 30-day Notice
S070 2014-05-22 30-day Notice
S069 2014-05-12 30-day Notice
S068 2014-04-21 Normal 180 Day Track
S067 2014-03-28 30-day Notice
S066 2014-03-13 30-day Notice
S065 2014-03-13 30-day Notice
S064 2014-03-07 30-day Notice
S063 2014-02-04 135 Review Track For 30-day Notice
S062 2013-12-23 30-day Notice
S061 2013-11-13 30-day Notice
S060 2013-10-25 30-day Notice
S059 2013-09-30 30-day Notice
S058 2013-09-24 30-day Notice
S057 2013-09-23 30-day Notice
S056 2013-09-23 30-day Notice
S055 2013-09-13 30-day Notice
S054 2013-09-09 30-day Notice
S053 2013-07-12 30-day Notice
S052 2013-05-31 135 Review Track For 30-day Notice
S051 2013-04-26 Normal 180 Day Track
S050 2013-03-18 30-day Notice
S049 2013-03-07 Normal 180 Day Track No User Fee
S048 2013-02-11 Real-time Process
S047 2013-02-08 135 Review Track For 30-day Notice
S046 2013-02-06 Normal 180 Day Track
S045 2013-01-22 30-day Notice
S044 2013-01-17 30-day Notice
S043 2012-12-11 30-day Notice
S042 2012-11-13 135 Review Track For 30-day Notice
S041
S040 2012-10-04 30-day Notice
S039 2012-09-25 30-day Notice
S038 2012-09-10 30-day Notice
S037 2012-08-20 30-day Notice
S036 2012-07-25 30-day Notice
S035 2012-07-23 135 Review Track For 30-day Notice
S034 2012-07-13 30-day Notice
S033 2012-05-09 30-day Notice
S032 2012-05-09 30-day Notice
S031 2012-05-07 30-day Notice
S030 2012-04-10 30-day Notice
S029 2012-03-26 30-day Notice
S028 2012-03-22 30-day Notice
S027 2012-03-16 30-day Notice
S026 2012-01-09 30-day Notice
S025 2011-12-21 30-day Notice
S024 2011-12-16 30-day Notice
S023 2011-12-08 30-day Notice
S022 2011-10-12 Normal 180 Day Track
S021 2011-08-15 Normal 180 Day Track No User Fee
S020 2011-08-10 Real-time Process
S019 2011-08-04 30-day Notice
S018 2011-07-29 Special (immediate Track)
S017 2011-07-25 30-day Notice
S016 2011-07-25 Normal 180 Day Track
S015 2011-07-22 30-day Notice
S014 2011-07-19 30-day Notice
S013 2011-07-12 Normal 180 Day Track No User Fee
S012 2011-07-06 30-day Notice
S011 2011-06-29 30-day Notice
S010 2011-06-10 30-day Notice
S009 2011-06-06 30-day Notice
S008 2011-05-25 Special (immediate Track)
S007 2011-05-23 30-day Notice
S006 2011-05-20 30-day Notice
S005 2011-05-18 30-day Notice
S004 2011-04-18 135 Review Track For 30-day Notice
S003 2011-04-08 30-day Notice
S002 2011-04-04 30-day Notice
S001 2011-03-16 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169651128 P080025 000
00613994639639 P080025 000
00613994572042 P080025 000
00613994572011 P080025 000
00613994571977 P080025 000
00613994571960 P080025 000
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00613994571922 P080025 000
00613994752390 P080025 000
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00613994752420 P080025 000
00643169651111 P080025 000
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00613994752444 P080025 000
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00643169651111 P080025 000
00643169651128 P080025 000
00643169651135 P080025 000
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00613994571922 P080025 000
00613994571946 P080025 000
00613994571960 P080025 000
00613994571977 P080025 000
00613994572011 P080025 000
00613994752406 P080025 000
00613994572042 P080025 000
00613994639639 P080025 000
00613994752437 P080025 000
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00613994752444 P080025 000
00613994752413 P080025 000
00613994571939 P080025 000
00613994756558 P080025 000
00643169089471 P080025 013
00643169089471 P080025 013
00643169013414 P080025 016
00643169013421 P080025 016
00643169013421 P080025 016
00643169170544 P080025 016
00643169013438 P080025 016
00643169013438 P080025 016
00643169170544 P080025 016
00643169013414 P080025 016
00613994997845 P080025 018
00613994997838 P080025 018
00613994997838 P080025 018
00613994997845 P080025 018
00613994752178 P080025 020
00613994752178 P080025 020
00613994913654 P080025 022
00613994913654 P080025 022
00643169103207 P080025 046
00643169103214 P080025 046
20613994926306 P080025 046
00643169567764 P080025 046
20643169036028 P080025 046
20613994926320 P080025 046
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20613994926313 P080025 046
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00643169021433 P080025 046
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00643169567764 P080025 046
00643169346260 P080025 049
00643169346253 P080025 049
00643169346277 P080025 049
00643169346277 P080025 049
00643169346253 P080025 049
00643169346260 P080025 049
00643169467330 P080025 051
00643169467323 P080025 051
00643169467330 P080025 051
00643169467323 P080025 051
20643169439409 P080025 083
20643169439430 P080025 083
00613994925947 P080025 083
00643169632080 P080025 083
20643169439423 P080025 083
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00613994925947 P080025 083
00643169632080 P080025 083
20643169439409 P080025 083
20643169439416 P080025 083
20643169439423 P080025 083
20643169439430 P080025 083
20643169439416 P080025 083
00643169021457 P080025 083
20643169721221 P080025 113
20643169721207 P080025 113
20643169721191 P080025 113
20643169721153 P080025 113
20643169721146 P080025 113
20643169721139 P080025 113
20643169721191 P080025 113
20643169721238 P080025 113
20643169721221 P080025 113
20643169721207 P080025 113
20643169721214 P080025 113
20643169721139 P080025 113
20643169721153 P080025 113
20643169721238 P080025 113
00643169721180 P080025 113
00643169721173 P080025 113
00643169721180 P080025 113
00643169721166 P080025 113
00643169721173 P080025 113
20643169721146 P080025 113
00643169721166 P080025 113
20643169721214 P080025 113
00643169725072 P080025 123
00643169725072 P080025 123
00643169968783 P080025 142
00643169968783 P080025 142
00643169834330 P080025 142
00643169834330 P080025 142
00643169834323 P080025 142
00643169834323 P080025 142
20763000060286 P080025 151
00643169953710 P080025 151
00643169953567 P080025 151
00643169953567 P080025 151
20763000060286 P080025 151
00643169953710 P080025 151
00643169974784 P080025 152
00643169974784 P080025 152
00643169974760 P080025 154
00643169864443 P080025 156
00643169864450 P080025 156
00643169864443 P080025 156
00643169864436 P080025 156
00643169864436 P080025 156
00643169864450 P080025 156
00763000187231 P080025 163
00763000024024 P080025 163
00763000058005 P080025 163
00763000024017 P080025 163
00763000024017 P080025 163
00763000058005 P080025 163
00763000024024 P080025 163
00763000187231 P080025 163

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