P030017S331

None

FDA Premarket Approval P030017 S331

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

DeviceP030017S331
Classification NameNone
Applicant
PMAP030017
SupplementS331

Supplemental Filings

Supplement NumberDateSupplement Type
P030017Original Filing
S332 2019-11-06 30-day Notice
S331
S330 2019-08-26 30-day Notice
S329 2019-08-16 30-day Notice
S328 2019-07-22 Real-time Process
S327 2019-06-17 Real-time Process
S326 2019-04-03 Real-time Process
S325 2019-03-12 30-day Notice
S324
S323
S322 2019-02-07 30-day Notice
S321 2018-10-29 30-day Notice
S320 2018-10-26 30-day Notice
S319 2018-08-24 30-day Notice
S318 2018-08-17 30-day Notice
S317 2018-07-03 30-day Notice
S316 2018-07-03 30-day Notice
S315 2018-07-02 30-day Notice
S314 2018-03-28 Real-time Process
S313 2018-03-27 30-day Notice
S312 2018-03-12 30-day Notice
S311 2018-02-12 30-day Notice
S310 2017-12-22 30-day Notice
S309 2017-12-22 30-day Notice
S308 2017-12-12 Real-time Process
S307 2017-11-09 Real-time Process
S306 2017-11-02 Real-time Process
S305 2017-11-01 30-day Notice
S304 2017-10-03 30-day Notice
S303 2017-10-03 30-day Notice
S302 2017-09-25 Real-time Process
S301 2017-08-03 30-day Notice
S300 2017-06-28 Normal 180 Day Track No User Fee
S299 2017-06-21 30-day Notice
S298 2017-06-13 30-day Notice
S297 2017-06-13 Normal 180 Day Track
S296 2017-06-08 Normal 180 Day Track No User Fee
S295 2017-05-30 Normal 180 Day Track No User Fee
S294 2017-05-23 30-day Notice
S293 2017-05-23 30-day Notice
S292 2017-05-22 30-day Notice
S291 2017-05-05 Real-time Process
S290 2017-04-24 30-day Notice
S289 2017-04-11 30-day Notice
S288 2017-03-14 Real-time Process
S287 2017-03-13 Real-time Process
S286 2017-02-28 30-day Notice
S285 2017-02-27 30-day Notice
S284 2017-02-27 30-day Notice
S283 2017-02-24 30-day Notice
S282 2017-02-22 30-day Notice
S281 2017-02-08 Real-time Process
S280 2017-02-01 Normal 180 Day Track No User Fee
S279 2017-01-31 Normal 180 Day Track No User Fee
S278 2017-01-30 Real-time Process
S277 2017-01-30 Normal 180 Day Track No User Fee
S276 2017-01-12 30-day Notice
S275 2016-12-27 Panel Track
S274 2016-12-23 Real-time Process
S273 2016-12-19 Real-time Process
S272 2016-12-19 30-day Notice
S271 2016-12-16 Real-time Process
S270 2016-12-14 Normal 180 Day Track
S269 2016-11-28 Normal 180 Day Track
S268 2016-11-08 30-day Notice
S267 2016-11-08 30-day Notice
S266 2016-11-04 Real-time Process
S265 2016-10-31 30-day Notice
S264 2016-10-25 30-day Notice
S263 2016-10-17 30-day Notice
S262 2016-10-17 30-day Notice
S261 2016-09-27 30-day Notice
S260 2016-09-26 30-day Notice
S259 2016-09-09 30-day Notice
S258 2016-09-06 30-day Notice
S257 2016-08-31 30-day Notice
S256 2016-08-18 30-day Notice
S255 2016-07-20 Real-time Process
S254 2016-07-01 30-day Notice
S253 2016-06-29 30-day Notice
S252 2016-06-02 30-day Notice
S251 2016-03-14 Real-time Process
S250 2016-03-10 Real-time Process
S249 2016-03-02 30-day Notice
S248 2016-02-23 30-day Notice
S247 2016-02-19 30-day Notice
S246 2016-02-05 30-day Notice
S245 2015-12-21 Normal 180 Day Track
S244 2015-12-18 30-day Notice
S243 2015-11-27 30-day Notice
S242 2015-11-04 30-day Notice
S241 2015-10-29 Normal 180 Day Track
S240 2015-10-26 30-day Notice
S239 2015-10-19 30-day Notice
S238 2015-10-19 30-day Notice
S237 2015-09-22 30-day Notice
S236 2015-09-11 30-day Notice
S235 2015-09-10 Normal 180 Day Track
S234 2015-08-14 Real-time Process
S233 2015-08-11 30-day Notice
S232 2015-08-03 30-day Notice
S231 2015-07-27 30-day Notice
S230 2015-06-26 Real-time Process
S229 2015-06-19 Real-time Process
S228 2015-05-29 30-day Notice
S227 2015-05-12 30-day Notice
S226 2015-05-04 30-day Notice
S225
S224 2015-04-17 30-day Notice
S223 2015-04-14 30-day Notice
S222 2015-04-10 30-day Notice
S221 2015-03-30 30-day Notice
S220 2015-03-17 30-day Notice
S219 2015-03-13 30-day Notice
S218 2015-03-11 30-day Notice
S217 2015-03-11 Normal 180 Day Track
S216 2015-02-27 Real-time Process
S215 2015-02-23 30-day Notice
S214 2015-02-11 30-day Notice
S213 2015-01-30 Real-time Process
S212 2015-01-26 30-day Notice
S211 2014-12-22 30-day Notice
S210 2014-11-24 Normal 180 Day Track
S209 2014-11-21 Real-time Process
S208 2014-10-27 30-day Notice
S207 2014-10-17 30-day Notice
S206 2014-10-17 135 Review Track For 30-day Notice
S205 2014-09-09 30-day Notice
S204 2014-09-09 30-day Notice
S203 2014-09-02 Special (immediate Track)
S202 2014-06-30 Normal 180 Day Track
S201 2014-06-02 Real-time Process
S200 2014-06-02 30-day Notice
S199 2014-05-14 30-day Notice
S198 2014-05-12 Real-time Process
S197 2014-05-07 30-day Notice
S196 2014-05-05 30-day Notice
S195 2014-04-04 30-day Notice
S194 2014-04-03 30-day Notice
S193 2014-03-24 30-day Notice
S192 2014-03-18 30-day Notice
S191 2014-03-14 Normal 180 Day Track
S190 2014-02-07 30-day Notice
S189 2014-01-27 30-day Notice
S188 2013-12-23 30-day Notice
S187 2013-12-23 30-day Notice
S186 2013-12-16 Normal 180 Day Track
S185 2013-11-22 Real-time Process
S184 2013-11-18 30-day Notice
S183 2013-11-18 30-day Notice
S182 2013-11-07 30-day Notice
S181 2013-10-29 Normal 180 Day Track
S180
S179 2013-08-27 30-day Notice
S178 2013-08-23 30-day Notice
S177 2013-08-21 30-day Notice
S176 2013-07-22 30-day Notice
S175 2013-07-19 30-day Notice
S174 2013-07-02 30-day Notice
S173 2013-07-02 30-day Notice
S172 2013-07-02 30-day Notice
S171 2013-06-21 30-day Notice
S170 2013-06-12 30-day Notice
S169 2013-06-11 30-day Notice
S168 2013-05-22 Real-time Process
S167 2013-05-21 30-day Notice
S166 2013-05-20 30-day Notice
S165 2013-05-20 30-day Notice
S164 2013-05-07 30-day Notice
S163 2013-05-07 30-day Notice
S162 2013-04-01 30-day Notice
S161 2013-04-01 30-day Notice
S160 2013-03-20 30-day Notice
S159 2013-03-18 30-day Notice
S158 2013-03-15 30-day Notice
S157 2013-03-04 Real-time Process
S156 2013-02-20 Real-time Process
S155 2013-02-15 30-day Notice
S154 2013-02-08 30-day Notice
S153 2013-02-01 30-day Notice
S152 2013-01-28 Normal 180 Day Track
S151 2012-12-26 30-day Notice
S150
S149
S148 2012-12-06 135 Review Track For 30-day Notice
S147 2012-12-06 30-day Notice
S146 2012-11-28 30-day Notice
S145 2012-09-27 Real-time Process
S144 2012-09-20 Real-time Process
S143 2012-09-12 30-day Notice
S142 2012-08-30 30-day Notice
S141 2012-08-17 30-day Notice
S140 2012-08-07 Real-time Process
S139 2012-07-16 30-day Notice
S138 2012-06-25 30-day Notice
S137 2012-06-22 30-day Notice
S136 2012-06-14 30-day Notice
S135 2012-05-09 30-day Notice
S134 2012-05-07 Normal 180 Day Track
S133 2012-04-24 30-day Notice
S132 2012-04-12 30-day Notice
S131 2012-03-05 30-day Notice
S130 2012-02-22 Real-time Process
S129 2012-02-09 30-day Notice
S128 2012-01-31 30-day Notice
S127 2012-01-20 30-day Notice
S126 2012-01-20 30-day Notice
S125 2011-12-09 30-day Notice
S124 2011-09-30 135 Review Track For 30-day Notice
S123 2011-09-12 30-day Notice
S122
S121 2011-06-27 30-day Notice
S120 2011-05-19 30-day Notice
S119 2011-04-26 Normal 180 Day Track
S118 2011-03-11 Real-time Process
S117 2011-03-01 30-day Notice
S116 2011-03-01 30-day Notice
S115 2010-12-21 30-day Notice
S114 2010-12-21 30-day Notice
S113 2010-12-13 30-day Notice
S112 2010-11-22 Real-time Process
S111 2010-11-18 30-day Notice
S110 2010-10-18 30-day Notice
S109 2010-09-13 30-day Notice
S108 2010-09-13 30-day Notice
S107 2010-08-05 30-day Notice
S106 2010-05-25 30-day Notice
S105 2010-05-06 135 Review Track For 30-day Notice
S104 2010-05-04 30-day Notice
S103 2010-03-29 30-day Notice
S102 2010-03-29 Normal 180 Day Track
S101 2010-03-09 30-day Notice
S100 2010-02-18 Normal 180 Day Track
S099 2010-01-26 30-day Notice
S098 2010-01-22 Real-time Process
S097
S096 2009-10-06 30-day Notice
S095 2009-09-15 Normal 180 Day Track
S094 2009-07-29 30-day Notice
S093 2009-06-10 Normal 180 Day Track
S092 2009-01-08 Real-time Process
S091 2008-11-25 Normal 180 Day Track
S090 2008-11-21 Special (immediate Track)
S089
S088 2008-11-03 Normal 180 Day Track
S087 2008-09-15 30-day Notice
S086 2008-09-15 30-day Notice
S085 2008-09-15 135 Review Track For 30-day Notice
S084 2008-10-21 Real-time Process
S083 2008-09-15 135 Review Track For 30-day Notice
S082 2008-10-21 Real-time Process
S081 2008-09-15 135 Review Track For 30-day Notice
S080 2008-09-05 30-day Notice
S079 2008-09-05 30-day Notice
S078
S077 2008-09-05 30-day Notice
S076 2008-09-05 135 Review Track For 30-day Notice
S075 2008-09-05 135 Review Track For 30-day Notice
S074 2008-09-05 135 Review Track For 30-day Notice
S073 2008-09-05 30-day Notice
S072 2008-09-05 30-day Notice
S071 2008-10-10 Normal 180 Day Track
S070
S069 2008-09-04 135 Review Track For 30-day Notice
S068
S067 2008-06-30 30-day Notice
S066
S065 2008-05-27 Normal 180 Day Track
S064
S063
S062 2008-04-11 135 Review Track For 30-day Notice
S061 2008-04-02 30-day Notice
S060 2008-03-31 30-day Notice
S059 2008-03-31 30-day Notice
S058
S057 2008-03-27 135 Review Track For 30-day Notice
S056
S055 2008-03-25 135 Review Track For 30-day Notice
S054 2008-03-24 135 Review Track For 30-day Notice
S053 2008-03-24 Normal 180 Day Track
S052 2008-03-21 135 Review Track For 30-day Notice
S051
S050 2008-03-20 30-day Notice
S049 2008-03-14 135 Review Track For 30-day Notice
S048 2008-03-14 30-day Notice
S047 2008-03-13 30-day Notice
S046 2008-03-13 135 Review Track For 30-day Notice
S045 2008-03-13 30-day Notice
S044
S043
S042 2008-03-12 135 Review Track For 30-day Notice
S041 2008-03-10 135 Review Track For 30-day Notice
S040 2008-03-10 30-day Notice
S039 2008-03-05 30-day Notice
S038
S037 2008-04-15 Real-time Process
S036
S035 2008-02-25 Normal 180 Day Track
S034 2008-02-25 30-day Notice
S033 2008-02-25 Normal 180 Day Track
S032 2008-02-25 30-day Notice
S031 2008-02-25 Normal 180 Day Track
S030 2007-11-07 Normal 180 Day Track No User Fee
S029 2007-10-11 Normal 180 Day Track No User Fee
S028 2007-10-04 30-day Notice
S027
S026 2007-08-08 135 Review Track For 30-day Notice
S025 2007-06-20 Normal 180 Day Track
S024 2007-04-26 Special (immediate Track)
S023 2007-04-06 Normal 180 Day Track
S022 2007-04-04 Normal 180 Day Track
S021 2007-03-16 30-day Notice
S020 2007-03-01 Normal 180 Day Track
S019 2007-02-15 Special (immediate Track)
S018 2006-12-04 Normal 180 Day Track
S017 2006-11-03 Normal 180 Day Track
S016 2006-11-03 Real-time Process
S015 2006-08-24 Normal 180 Day Track
S014 2006-04-14 Normal 180 Day Track
S013 2006-04-11 Normal 180 Day Track
S012 2006-03-22 Real-time Process
S011 2005-11-07 Real-time Process
S010 2005-10-13 Real-time Process
S009
S008 2005-05-31 Normal 180 Day Track
S007 2005-05-03 Normal 180 Day Track No User Fee
S006 2005-03-09 30-day Notice
S005
S004 2004-11-12 Special (immediate Track)
S003 2004-08-17 Real-time Process
S002 2004-06-09 Real-time Process
S001 2004-06-03 30-day Notice

NIH GUDID Devices

Device IDPMASupp
08714729982579 P030017 323
08714729990376 P030017 326
08714729991380 P030017 331
08714729991366 P030017 331
08714729991229 P030017 331
08714729991212 P030017 331

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.