P030054S380

None

FDA Premarket Approval P030054 S380

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

DeviceP030054S380
Classification NameNone
Applicant
PMAP030054
SupplementS380

Supplemental Filings

Supplement NumberDateSupplement Type
P030054Original Filing
S385 2020-08-31 30-day Notice
S384
S383 2020-07-17 30-day Notice
S382
S381
S380
S379 2020-05-22 30-day Notice
S378 2020-04-24 30-day Notice
S377 2020-02-27 30-day Notice
S376 2020-02-13 30-day Notice
S375 2019-12-09 30-day Notice
S374
S373 2019-10-30 Real-time Process
S372 2019-10-09 Normal 180 Day Track No User Fee
S371 2019-09-23 30-day Notice
S370 2019-08-07 30-day Notice
S369 2019-07-24 30-day Notice
S368
S367 2018-11-30 30-day Notice
S366 2018-11-23 30-day Notice
S365 2018-11-20 30-day Notice
S364 2018-10-29 Real-time Process
S363 2018-10-09 30-day Notice
S362 2018-10-02 30-day Notice
S361 2018-10-01 30-day Notice
S360 2018-09-28 30-day Notice
S359 2018-07-25 Normal 180 Day Track No User Fee
S358 2018-07-17 30-day Notice
S357 2018-07-02 30-day Notice
S356 2018-06-28 Normal 180 Day Track
S355 2018-06-20 Normal 180 Day Track
S354 2018-05-21 30-day Notice
S353 2018-04-05 30-day Notice
S352 2018-03-14 30-day Notice
S351 2018-03-12 30-day Notice
S350 2018-03-05 30-day Notice
S349 2018-02-27 30-day Notice
S348 2018-01-31 30-day Notice
S347 2018-01-29 30-day Notice
S346 2018-01-26 30-day Notice
S345 2018-01-18 30-day Notice
S344 2018-01-18 Normal 180 Day Track
S343 2017-12-21 30-day Notice
S342 2017-11-13 30-day Notice
S341 2017-11-13 30-day Notice
S340 2017-10-30 Real-time Process
S339 2017-10-10 30-day Notice
S338 2017-09-22 30-day Notice
S337 2017-09-21 30-day Notice
S336 2017-08-16 30-day Notice
S335 2017-08-01 30-day Notice
S334 2017-07-31 Real-time Process
S333 2017-07-31 Real-time Process
S332 2017-07-03 Normal 180 Day Track
S331 2017-06-29 30-day Notice
S330 2017-06-27 30-day Notice
S329 2017-05-17 Normal 180 Day Track
S328 2017-04-06 30-day Notice
S327 2017-04-03 Real-time Process
S326 2017-04-03 Normal 180 Day Track
S325 2017-02-28 30-day Notice
S324 2017-02-24 30-day Notice
S323 2017-02-17 135 Review Track For 30-day Notice
S322 2017-02-10 30-day Notice
S321 2017-02-07 Real-time Process
S320 2017-02-01 Real-time Process
S319 2017-01-30 30-day Notice
S318 2017-01-26 30-day Notice
S317 2017-01-25 30-day Notice
S316 2016-12-14 Real-time Process
S315 2016-12-13 30-day Notice
S314 2016-11-14 Normal 180 Day Track
S313 2016-10-21 30-day Notice
S312 2016-10-12 30-day Notice
S311 2016-09-27 135 Review Track For 30-day Notice
S310 2016-09-13 135 Review Track For 30-day Notice
S309
S308 2016-07-05 30-day Notice
S307 2016-07-05 Real-time Process
S306 2016-06-24 30-day Notice
S305 2016-06-22 30-day Notice
S304 2016-04-26 Real-time Process
S303 2016-04-12 30-day Notice
S302 2016-04-04 Real-time Process
S301 2016-02-03 Real-time Process
S300
S299 2016-01-21 30-day Notice
S298 2016-01-19 30-day Notice
S297 2016-01-12 30-day Notice
S296 2015-11-25 30-day Notice
S295 2015-10-26 135 Review Track For 30-day Notice
S294 2015-09-29 Real-time Process
S293 2015-09-17 30-day Notice
S292 2015-09-15 Normal 180 Day Track
S291 2015-08-17 Normal 180 Day Track
S290 2015-08-17 Real-time Process
S289 2015-08-13 30-day Notice
S288 2015-08-10 30-day Notice
S287 2015-07-23 Real-time Process
S286 2015-05-19 Real-time Process
S285 2015-03-25 30-day Notice
S284 2015-02-11 Normal 180 Day Track
S283 2015-02-04 Real-time Process
S282 2015-01-28 30-day Notice
S281 2014-12-18 Real-time Process
S280 2014-12-08 Real-time Process
S279 2014-11-17 30-day Notice
S278 2014-11-03 Real-time Process
S277 2014-10-27 30-day Notice
S276 2014-10-20 Real-time Process
S275 2014-09-26 30-day Notice
S274 2014-08-22 Real-time Process
S273 2014-07-02 Normal 180 Day Track
S272 2014-06-30 30-day Notice
S271 2014-06-16 30-day Notice
S270 2014-05-30 30-day Notice
S269 2014-05-28 30-day Notice
S268 2014-05-22 Real-time Process
S267 2014-04-30 30-day Notice
S266 2014-04-21 30-day Notice
S265 2014-04-15 Real-time Process
S264
S263 2014-02-18 30-day Notice
S262 2014-02-28 Real-time Process
S261 2014-02-05 30-day Notice
S260 2014-02-05 30-day Notice
S259 2014-01-24 Real-time Process
S258 2014-01-23 30-day Notice
S257
S256 2014-01-13 30-day Notice
S255 2013-11-29 30-day Notice
S254 2013-11-21 Normal 180 Day Track
S253 2013-10-28 30-day Notice
S252 2013-07-31 30-day Notice
S251 2013-05-13 30-day Notice
S250 2013-05-13 30-day Notice
S249
S248 2013-05-13 30-day Notice
S247
S246 2013-06-03 Real-time Process
S245 2013-04-15 30-day Notice
S244 2013-03-14 30-day Notice
S243 2013-01-30 30-day Notice
S242 2012-12-11 135 Review Track For 30-day Notice
S241 2012-12-05 Normal 180 Day Track
S240
S239 2012-11-21 30-day Notice
S238 2012-11-14 Normal 180 Day Track
S237 2012-10-15 Normal 180 Day Track
S236 2012-10-15 Normal 180 Day Track No User Fee
S235 2012-09-28 30-day Notice
S234
S233 2012-09-13 30-day Notice
S232 2012-09-05 Real-time Process
S231 2012-08-27 30-day Notice
S230 2012-08-16 Real-time Process
S229
S228 2012-08-07 30-day Notice
S227 2012-07-19 Normal 180 Day Track No User Fee
S226 2012-07-11 Normal 180 Day Track
S225 2012-07-10 30-day Notice
S224 2012-05-30 Real-time Process
S223 2012-05-25 Normal 180 Day Track
S222 2012-05-22 30-day Notice
S221 2012-04-03 30-day Notice
S220 2012-02-29 Real-time Process
S219
S218 2012-02-22 Real-time Process
S217 2012-02-13 135 Review Track For 30-day Notice
S216 2012-02-13 30-day Notice
S215 2012-02-10 30-day Notice
S214 2012-01-04 Normal 180 Day Track No User Fee
S213
S212 2011-12-23 Normal 180 Day Track No User Fee
S211
S210
S209 2011-12-05 30-day Notice
S208 2011-11-30 135 Review Track For 30-day Notice
S207 2011-11-04 30-day Notice
S206 2011-11-01 Normal 180 Day Track
S205 2011-10-26 30-day Notice
S204 2011-10-25 30-day Notice
S203 2011-09-13 30-day Notice
S202 2011-09-12 Real-time Process
S201 2011-09-09 30-day Notice
S200 2011-09-02 Real-time Process
S199 2011-08-31 Real-time Process
S198 2011-08-08 Real-time Process
S197 2011-07-26 Real-time Process
S196 2011-07-19 Normal 180 Day Track
S195 2011-07-18 30-day Notice
S194 2011-07-15 30-day Notice
S193 2011-06-28 Real-time Process
S192 2011-06-20 Real-time Process
S191 2011-05-18 Normal 180 Day Track No User Fee
S190 2011-05-11 135 Review Track For 30-day Notice
S189 2011-05-02 Normal 180 Day Track
S188 2011-04-19 Normal 180 Day Track
S187 2011-04-11 30-day Notice
S186 2011-04-05 30-day Notice
S185 2011-04-05 30-day Notice
S184
S183 2011-03-22 135 Review Track For 30-day Notice
S182 2011-03-18 Real-time Process
S181 2011-03-14 Normal 180 Day Track
S180 2011-03-09 135 Review Track For 30-day Notice
S179 2010-12-09 30-day Notice
S178 2010-12-03 30-day Notice
S177 2010-11-23 Normal 180 Day Track
S176 2010-11-22 135 Review Track For 30-day Notice
S175 2010-11-15 30-day Notice
S174 2010-11-12 30-day Notice
S173 2010-10-29 Normal 180 Day Track
S172 2010-09-29 30-day Notice
S171 2010-09-20 30-day Notice
S170 2010-08-20 Real-time Process
S169 2010-08-19 Real-time Process
S168 2010-08-16 Normal 180 Day Track No User Fee
S167 2010-07-30 Real-time Process
S166 2010-07-29 30-day Notice
S165 2010-07-26 Real-time Process
S164 2010-07-19 30-day Notice
S163 2010-07-19 30-day Notice
S162 2010-07-13 Normal 180 Day Track No User Fee
S161 2010-07-07 30-day Notice
S160 2010-07-06 30-day Notice
S159 2010-07-06 Real-time Process
S158 2010-06-30 Real-time Process
S157 2010-07-22 Real-time Process
S156 2010-06-24 Special (immediate Track)
S155 2010-06-22 Real-time Process
S154 2010-06-17 30-day Notice
S153 2010-06-04 Normal 180 Day Track
S152 2010-05-21 30-day Notice
S151 2010-05-21 30-day Notice
S150 2010-05-20 Normal 180 Day Track
S149 2010-05-19 Real-time Process
S148 2010-04-30 Real-time Process
S147 2010-03-26 30-day Notice
S146 2010-02-05 Normal 180 Day Track
S145 2010-02-04 30-day Notice
S144 2010-01-25 135 Review Track For 30-day Notice
S143 2009-12-24 30-day Notice
S142 2009-11-25 Normal 180 Day Track No User Fee
S141 2009-11-05 Normal 180 Day Track
S140 2009-10-29 30-day Notice
S139 2009-10-22 Real-time Process
S138 2009-10-19 30-day Notice
S137 2009-10-02 135 Review Track For 30-day Notice
S136 2009-09-14 30-day Notice
S135 2009-09-14 Real-time Process
S134 2009-09-02 30-day Notice
S133 2009-09-01 Real-time Process
S132 2009-08-28 30-day Notice
S131 2009-08-04 Normal 180 Day Track
S130 2009-07-16 Normal 180 Day Track
S129 2009-06-23 30-day Notice
S128 2009-06-18 30-day Notice
S127 2009-06-10 30-day Notice
S126 2009-05-21 30-day Notice
S125 2009-05-11 30-day Notice
S124
S123 2009-04-08 Real-time Process
S122 2009-04-02 Real-time Process
S121 2009-03-30 30-day Notice
S120 2009-03-23 Real-time Process
S119 2009-03-04 Real-time Process
S118 2009-02-17 Real-time Process
S117 2009-02-10 Real-time Process
S116 2009-02-06 Normal 180 Day Track No User Fee
S115 2009-01-30 30-day Notice
S114 2009-01-21 Normal 180 Day Track No User Fee
S113 2009-01-02 Real-time Process
S112 2008-12-31 Real-time Process
S111 2008-11-28 Real-time Process
S110 2008-11-24 Real-time Process
S109 2008-11-13 Real-time Process
S108 2008-11-07 30-day Notice
S107 2008-10-22 Real-time Process
S106 2008-10-15 Real-time Process
S105 2008-09-11 30-day Notice
S104 2008-09-04 Normal 180 Day Track No User Fee
S103 2008-08-19 Real-time Process
S102 2008-08-11 30-day Notice
S101 2008-08-11 30-day Notice
S100 2008-08-11 Special (immediate Track)
S099 2008-07-30 Real-time Process
S098 2008-07-24 135 Review Track For 30-day Notice
S097 2008-07-17 Real-time Process
S096 2008-06-17 Real-time Process
S095 2008-06-13 30-day Notice
S094 2008-06-02 Real-time Process
S093 2008-05-30 Real-time Process
S092 2008-05-28 Real-time Process
S091 2008-05-23 30-day Notice
S090 2008-05-22 30-day Notice
S089 2008-05-21 30-day Notice
S088 2008-05-09 Real-time Process
S087 2008-04-15 30-day Notice
S086 2008-04-10 Real-time Process
S085 2008-03-25 Real-time Process
S084 2008-03-19 Real-time Process
S083 2008-03-10 Real-time Process
S082 2008-02-12 Special (immediate Track)
S081 2008-02-06 Real-time Process
S080 2008-02-04 30-day Notice
S079 2008-02-01 Normal 180 Day Track No User Fee
S078 2007-12-26 30-day Notice
S077 2007-12-20 30-day Notice
S076 2007-12-13 30-day Notice
S075 2007-12-06 30-day Notice
S074 2007-10-24 Real-time Process
S073 2007-10-22 Real-time Process
S072 2007-10-19 Normal 180 Day Track No User Fee
S071 2007-09-28 30-day Notice
S070 2007-09-21 Real-time Process
S069 2007-09-20 30-day Notice
S068 2007-09-13 30-day Notice
S067 2007-09-05 Normal 180 Day Track
S066 2007-08-30 30-day Notice
S065 2007-08-23 30-day Notice
S064 2007-08-13 Real-time Process
S063 2007-08-13 Normal 180 Day Track
S062 2007-07-19 30-day Notice
S061 2007-07-19 30-day Notice
S060 2007-07-19 30-day Notice
S059 2007-06-25 30-day Notice
S058 2007-05-07 30-day Notice
S057 2007-04-25 30-day Notice
S056 2007-04-23 Normal 180 Day Track
S055 2007-04-17 30-day Notice
S054 2007-04-16 135 Review Track For 30-day Notice
S053 2007-04-16 30-day Notice
S052 2007-04-13 Real-time Process
S051 2007-04-06 Real-time Process
S050 2007-04-06 Normal 180 Day Track
S049 2007-02-05 Normal 180 Day Track
S048 2006-12-21 30-day Notice
S047 2006-12-13 30-day Notice
S046 2006-11-30 Real-time Process
S045 2006-11-21 Real-time Process
S044 2006-10-25 30-day Notice
S043 2006-10-20 Real-time Process
S042 2006-10-18 30-day Notice
S041 2006-10-12 Real-time Process
S040 2006-10-06 Real-time Process
S039 2006-09-27 30-day Notice
S038
S037 2006-09-07 30-day Notice
S036 2006-09-07 30-day Notice
S035 2006-08-28 30-day Notice
S034 2006-07-19 Normal 180 Day Track
S033 2006-07-13 30-day Notice
S032 2006-07-03 30-day Notice
S031 2006-06-26 Real-time Process
S030 2006-06-07 Real-time Process
S029 2006-05-09 30-day Notice
S028 2006-04-26 30-day Notice
S027
S026
S025 2006-03-30 Real-time Process
S024 2006-03-07 Real-time Process
S023 2006-02-17 Normal 180 Day Track
S022 2006-02-03 Real-time Process
S021 2006-01-25 30-day Notice
S020 2005-12-20 Real-time Process
S019 2005-11-09 Normal 180 Day Track
S018 2005-11-07 Normal 180 Day Track
S017 2005-11-03 30-day Notice
S016 2005-10-26 135 Review Track For 30-day Notice
S015 2005-10-24 Real-time Process
S014 2005-10-11 Real-time Process
S013 2005-10-03 30-day Notice
S012 2005-09-19 30-day Notice
S011 2005-07-29 Real-time Process
S010 2005-06-06 Panel Track
S009 2005-04-21 30-day Notice
S008 2005-04-18 Real-time Process
S007 2005-04-12 Real-time Process
S006 2005-03-02 Real-time Process
S005 2005-01-24 Real-time Process
S004 2004-12-17 Normal 180 Day Track
S003 2004-09-27 Real-time Process
S002 2004-08-16 Normal 180 Day Track No User Fee
S001 2004-07-01 Normal 180 Day Track

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