P960009S341

None

FDA Premarket Approval P960009 S341

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

DeviceP960009S341
Classification NameNone
Applicant
PMAP960009
SupplementS341

Supplemental Filings

Supplement NumberDateSupplement Type
P960009Original Filing
S360 2019-09-27 30-day Notice
S359 2019-09-16 30-day Notice
S358 2019-08-19 30-day Notice
S357 2019-08-05 Special (immediate Track)
S356 2019-07-29 30-day Notice
S355
S354 2019-07-16 30-day Notice
S353 2019-07-01 30-day Notice
S352 2019-06-06 30-day Notice
S351
S350 2019-05-06 30-day Notice
S349 2019-04-30 30-day Notice
S348 2019-04-26 30-day Notice
S347
S346 2019-04-05 30-day Notice
S345 2019-04-01 30-day Notice
S344 2019-03-21 Special (immediate Track)
S343 2019-03-07 30-day Notice
S342 2019-03-04 30-day Notice
S341
S340 2019-02-21 30-day Notice
S339 2019-02-14 Real-time Process
S338 2019-02-13 30-day Notice
S337 2018-12-26 Real-time Process
S336 2018-12-18 Real-time Process
S335 2018-12-11 30-day Notice
S334 2018-12-11 30-day Notice
S333
S332 2018-11-21 Real-time Process
S331 2018-11-13 30-day Notice
S330 2018-11-06 30-day Notice
S329 2018-10-30 30-day Notice
S328 2018-10-19 30-day Notice
S327 2018-10-10 30-day Notice
S326 2018-10-01 30-day Notice
S325 2018-09-14 30-day Notice
S324 2018-09-04 135 Review Track For 30-day Notice
S323 2018-08-28 30-day Notice
S322
S321 2018-08-02 30-day Notice
S320 2018-07-17 30-day Notice
S319 2018-06-18 30-day Notice
S318 2018-05-24 Normal 180 Day Track No User Fee
S317 2018-05-18 30-day Notice
S316 2018-05-16 30-day Notice
S315 2018-05-07 30-day Notice
S314 2018-05-02 30-day Notice
S313 2018-04-26 30-day Notice
S312 2018-04-16 30-day Notice
S311 2018-03-22 30-day Notice
S310 2018-03-12 30-day Notice
S309 2018-01-05 135 Review Track For 30-day Notice
S308 2017-12-18 30-day Notice
S307 2017-12-15 30-day Notice
S306 2017-11-20 30-day Notice
S305 2017-11-20 30-day Notice
S304 2017-11-16 Normal 180 Day Track
S303
S302 2017-11-13 30-day Notice
S301 2017-11-06 30-day Notice
S300 2017-10-20 30-day Notice
S299 2017-09-27 30-day Notice
S298 2017-09-20 30-day Notice
S297 2017-09-20 Special (immediate Track)
S296 2017-09-13 30-day Notice
S295 2017-09-08 30-day Notice
S294 2017-09-05 Normal 180 Day Track No User Fee
S293 2017-09-01 Normal 180 Day Track No User Fee
S292 2017-08-22 135 Review Track For 30-day Notice
S291 2017-08-03 135 Review Track For 30-day Notice
S290 2017-07-28 30-day Notice
S289 2017-07-27 30-day Notice
S288 2017-07-27 30-day Notice
S287 2017-07-17 30-day Notice
S286 2017-07-17 Real-time Process
S285 2017-07-17 30-day Notice
S284 2017-06-07 Real-time Process
S283 2017-05-23 30-day Notice
S282 2017-05-18 30-day Notice
S281 2017-05-03 30-day Notice
S280 2017-04-28 30-day Notice
S279 2017-04-26 30-day Notice
S278 2017-04-25 30-day Notice
S277 2017-04-14 30-day Notice
S276 2017-04-03 30-day Notice
S275 2017-04-03 30-day Notice
S274 2017-03-29 30-day Notice
S273 2017-03-10 Special (immediate Track)
S272 2017-03-09 30-day Notice
S271 2017-03-03 30-day Notice
S270 2017-01-13 30-day Notice
S269 2017-01-11 30-day Notice
S268 2017-01-09 30-day Notice
S267 2016-11-23 30-day Notice
S266 2016-11-21 30-day Notice
S265 2016-11-14 30-day Notice
S264 2016-11-03 30-day Notice
S263 2016-08-15 30-day Notice
S262 2016-08-15 30-day Notice
S261 2016-08-12 30-day Notice
S260 2016-08-01 30-day Notice
S259 2016-07-29 30-day Notice
S258 2016-07-25 30-day Notice
S257 2016-06-30 30-day Notice
S256 2016-06-27 30-day Notice
S255 2016-06-27 30-day Notice
S254 2016-06-09 30-day Notice
S253 2016-06-07 30-day Notice
S252 2016-06-06 30-day Notice
S251 2016-05-31 30-day Notice
S250 2016-04-27 30-day Notice
S249 2016-04-05 30-day Notice
S248 2016-03-04 30-day Notice
S247 2016-02-11 30-day Notice
S246 2016-02-08 Normal 180 Day Track
S245 2015-12-28 30-day Notice
S244 2015-12-23 30-day Notice
S243 2015-12-14 Real-time Process
S242 2015-11-23 30-day Notice
S241 2015-10-29 30-day Notice
S240 2015-10-13 30-day Notice
S239 2015-09-30 30-day Notice
S238 2015-09-14 30-day Notice
S237 2015-08-31 135 Review Track For 30-day Notice
S236 2015-07-23 30-day Notice
S235 2015-07-14 30-day Notice
S234 2015-06-17 30-day Notice
S233 2015-06-16 30-day Notice
S232 2015-06-08 30-day Notice
S231 2015-06-01 30-day Notice
S230 2015-05-28 Special (immediate Track)
S229 2015-05-21 Normal 180 Day Track
S228 2015-05-15 30-day Notice
S227 2015-05-11 30-day Notice
S226 2015-04-30 30-day Notice
S225 2015-04-28 30-day Notice
S224 2015-03-19 30-day Notice
S223 2015-03-09 30-day Notice
S222 2015-03-06 30-day Notice
S221 2015-02-27 30-day Notice
S220 2015-02-27 Real-time Process
S219 2015-02-24 Panel Track
S218 2015-02-18 30-day Notice
S217 2015-02-04 30-day Notice
S216 2015-01-23 30-day Notice
S215 2015-01-12 30-day Notice
S214 2015-01-12 30-day Notice
S213 2015-01-09 30-day Notice
S212 2014-11-24 30-day Notice
S211 2014-11-17 Normal 180 Day Track
S210 2014-10-23 30-day Notice
S209 2014-09-18 30-day Notice
S208 2014-09-16 30-day Notice
S207 2014-09-16 30-day Notice
S206 2014-09-04 30-day Notice
S205 2014-08-25 30-day Notice
S204 2014-08-20 30-day Notice
S203 2014-08-11 Real-time Process
S202 2014-08-01 30-day Notice
S201 2014-08-01 Special (immediate Track)
S200 2014-07-30 30-day Notice
S199 2014-07-03 30-day Notice
S198 2014-07-02 30-day Notice
S197 2014-06-19 Normal 180 Day Track
S196 2014-06-04 30-day Notice
S195 2014-05-30 30-day Notice
S194 2014-04-25 30-day Notice
S193 2014-03-31 Special (immediate Track)
S192 2014-03-28 30-day Notice
S191 2014-03-13 30-day Notice
S190 2014-03-05 30-day Notice
S189 2014-02-18 30-day Notice
S188 2014-02-04 135 Review Track For 30-day Notice
S187 2013-12-23 30-day Notice
S186 2013-11-13 30-day Notice
S185 2013-10-25 30-day Notice
S184 2013-09-30 30-day Notice
S183 2013-09-24 30-day Notice
S182 2013-09-23 30-day Notice
S181 2013-09-23 30-day Notice
S180 2013-09-13 30-day Notice
S179 2013-09-09 30-day Notice
S178 2013-07-29 30-day Notice
S177 2013-07-29 30-day Notice
S176 2013-07-17 30-day Notice
S175 2013-07-12 30-day Notice
S174 2013-07-03 30-day Notice
S173 2013-06-06 Real-time Process
S172 2013-05-31 135 Review Track For 30-day Notice
S171 2013-04-29 30-day Notice
S170 2013-03-21 135 Review Track For 30-day Notice
S169 2013-03-18 Normal 180 Day Track No User Fee
S168 2013-03-18 30-day Notice
S167 2013-02-11 Real-time Process
S166 2013-02-08 135 Review Track For 30-day Notice
S165 2013-02-07 Real-time Process
S164 2013-02-01 30-day Notice
S163
S162 2013-01-22 30-day Notice
S161 2012-12-11 30-day Notice
S160 2012-10-05 Real-time Process
S159 2012-10-04 30-day Notice
S158 2012-09-25 30-day Notice
S157 2012-09-10 30-day Notice
S156 2012-08-31 Normal 180 Day Track No User Fee
S155 2012-08-20 30-day Notice
S154 2012-08-14 30-day Notice
S153 2012-07-25 30-day Notice
S152 2012-07-23 135 Review Track For 30-day Notice
S151 2012-07-13 30-day Notice
S150 2012-07-02 30-day Notice
S149 2012-06-22 Real-time Process
S148 2012-05-17 30-day Notice
S147 2012-05-09 30-day Notice
S146 2012-05-09 30-day Notice
S145 2012-05-07 30-day Notice
S144 2012-04-30 30-day Notice
S143 2012-04-10 30-day Notice
S142 2012-04-04 Special (immediate Track)
S141 2012-04-02 30-day Notice
S140
S139 2012-03-26 30-day Notice
S138 2012-03-22 30-day Notice
S137 2012-03-16 30-day Notice
S136 2011-12-21 30-day Notice
S135 2011-12-16 30-day Notice
S134 2011-12-12 Real-time Process
S133 2011-12-08 30-day Notice
S132 2011-11-04 30-day Notice
S131 2011-10-11 30-day Notice
S130 2011-10-11 30-day Notice
S129 2011-10-05 30-day Notice
S128 2011-10-04 30-day Notice
S127 2011-09-22 30-day Notice
S126
S125 2011-07-29 Special (immediate Track)
S124 2011-07-22 30-day Notice
S123 2011-07-19 30-day Notice
S122 2011-07-06 30-day Notice
S121 2011-06-29 30-day Notice
S120 2011-06-10 30-day Notice
S119 2011-06-06 30-day Notice
S118 2011-05-23 30-day Notice
S117 2011-05-20 30-day Notice
S116 2011-05-18 30-day Notice
S115 2011-04-18 135 Review Track For 30-day Notice
S114 2011-04-04 30-day Notice
S113 2011-03-30 30-day Notice
S112 2011-03-16 135 Review Track For 30-day Notice
S111 2011-02-16 30-day Notice
S110 2011-02-07 30-day Notice
S109 2011-02-07 30-day Notice
S108 2011-02-03 Real-time Process
S107 2010-12-27 30-day Notice
S106 2010-12-21 Special (immediate Track)
S105 2010-12-08 30-day Notice
S104 2010-12-07 30-day Notice
S103 2010-11-26 30-day Notice
S102 2010-11-24 30-day Notice
S101 2010-11-22 30-day Notice
S100 2010-10-25 30-day Notice
S099 2010-10-12 30-day Notice
S098
S097 2010-09-14 30-day Notice
S096 2010-08-31 30-day Notice
S095 2010-08-17 30-day Notice
S094 2010-08-11 30-day Notice
S093 2010-08-11 30-day Notice
S092 2010-08-02 Normal 180 Day Track
S091 2010-07-30 30-day Notice
S090 2010-08-02 Normal 180 Day Track
S089 2010-07-08 135 Review Track For 30-day Notice
S088 2010-06-30 30-day Notice
S087 2010-06-28 30-day Notice
S086
S085 2010-06-03 30-day Notice
S084 2010-06-01 30-day Notice
S083 2010-05-03 Real-time Process
S082 2010-04-20 30-day Notice
S081 2010-04-15 30-day Notice
S080 2010-04-01 Special (immediate Track)
S079 2010-04-02 30-day Notice
S078 2010-02-01 30-day Notice
S077 2010-01-27 30-day Notice
S076 2009-12-23 30-day Notice
S075 2010-01-07 Real-time Process
S074 2009-12-14 30-day Notice
S073 2009-12-03 Normal 180 Day Track
S072 2009-11-18 30-day Notice
S071 2009-08-28 Real-time Process
S070 2009-08-24 Normal 180 Day Track No User Fee
S069 2009-08-20 30-day Notice
S068
S067 2009-04-15 Real-time Process
S066 2009-04-14 30-day Notice
S065 2009-04-13 Special (immediate Track)
S064 2009-02-24 30-day Notice
S063 2009-02-12 30-day Notice
S062 2009-02-06 30-day Notice
S061 2009-01-02 30-day Notice
S060 2008-12-19 Normal 180 Day Track No User Fee
S059 2008-12-17 30-day Notice
S058 2008-12-15 30-day Notice
S057 2008-12-11 Normal 180 Day Track No User Fee
S056
S055 2008-07-24 135 Review Track For 30-day Notice
S054 2008-06-30 135 Review Track For 30-day Notice
S053
S052 2008-06-06 Normal 180 Day Track
S051 2008-04-24 Normal 180 Day Track
S050 2008-04-23 30-day Notice
S049 2008-04-14 Normal 180 Day Track No User Fee
S048 2008-03-26 30-day Notice
S047 2008-03-10 135 Review Track For 30-day Notice
S046 2008-02-25 30-day Notice
S045 2007-11-23 30-day Notice
S044 2007-10-09 30-day Notice
S043 2007-09-17 135 Review Track For 30-day Notice
S042 2007-09-17 Special (immediate Track)
S041 2007-08-31 Real-time Process
S040 2006-06-05 Real-time Process
S039 2006-05-15 Real-time Process
S038
S037 2006-02-06 Special (immediate Track)
S036 2005-12-28 Real-time Process
S035 2005-11-04 Special (immediate Track)
S034 2005-11-02 30-day Notice
S033 2005-10-06 135 Review Track For 30-day Notice
S032 2005-03-23 30-day Notice
S031
S030 2004-07-20 Normal 180 Day Track No User Fee
S029 2004-06-01 Real-time Process
S028 2003-08-25 Normal 180 Day Track No User Fee
S027 2002-08-27 Normal 180 Day Track
S026 2002-07-15 Real-time Process
S025 2002-05-10 Normal 180 Day Track
S024 2002-02-25 Real-time Process
S023 2001-12-07 30-day Notice
S022 2001-11-13 Special (immediate Track)
S021 2001-09-19 Special (immediate Track)
S020 2001-07-10 Special (immediate Track)
S019 2001-07-03 Normal 180 Day Track
S018 2001-06-15 Special (immediate Track)
S017 2001-05-23 Special (immediate Track)
S016 2001-04-16 Normal 180 Day Track
S015 2000-11-16 30-day Notice
S014 2000-10-26 Normal 180 Day Track
S013
S012 2000-04-18 Special (immediate Track)
S011
S010 2000-02-22 Normal 180 Day Track
S009 2000-01-18 Real-time Process
S008 1999-10-28 Normal 180 Day Track
S007 1999-09-30 Panel Track
S006 1999-02-24 Special (immediate Track)
S005 1999-01-12 Real-time Process
S004 1998-12-29 Special (immediate Track)
S003 1998-10-08 Real-time Process
S002 1998-03-05 Normal 180 Day Track
S001 1997-11-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00613994637918 P960009 007
00613994637918 P960009 007
00721902656408 P960009 026
00721902656408 P960009 026
00721902036378 P960009 027
00721902036378 P960009 027
00613994348692 P960009 051
00613994348692 P960009 051
00613994500793 P960009 051
00613994852731 P960009 051
00613994852731 P960009 051
00613994500793 P960009 051
00613994877284 P960009 080
00613994877277 P960009 080
00613994808349 P960009 080
00613994877277 P960009 080
00613994877284 P960009 080
00613994808349 P960009 080
00613994934611 P960009 083
00643169105492 P960009 083
00643169100770 P960009 083
00643169100770 P960009 083
00613994934611 P960009 083
00643169105492 P960009 083
00643169512993 P960009 142
00643169512993 P960009 142
00643169529786 P960009 149
00643169529762 P960009 149
00643169529779 P960009 149
00643169529793 P960009 149
00643169529779 P960009 149
00643169529786 P960009 149
00643169529793 P960009 149
00613994761064 P960009 149
00613994761088 P960009 149
00613994761064 P960009 149
00613994761088 P960009 149
00643169529762 P960009 149
00613994981356 P960009 170
00613994981356 P960009 170
00643169518933 P960009 197
00643169518988 P960009 197
00643169518933 P960009 197
00643169518988 P960009 197
00643169449107 P960009 203
00643169449107 P960009 203
00643169516571 P960009 210
00643169516540 P960009 210
00643169516557 P960009 210
00643169516571 P960009 210
00643169516540 P960009 210
00643169516557 P960009 210
00643169752283 P960009 211
00643169752276 P960009 211
00643169752290 P960009 211
00643169613713 P960009 211
00643169449169 P960009 211
00643169449145 P960009 211
00643169449152 P960009 211
00643169449169 P960009 211
00643169752283 P960009 211
00643169752290 P960009 211
00643169752276 P960009 211
00643169449152 P960009 211
00643169613713 P960009 211
00643169449145 P960009 211
00763000017606 P960009 219
00763000175719 P960009 219
00613994582454 P960009 219
00643169953703 P960009 219
00643169510470 P960009 219
00763000017606 P960009 219
00643169510470 P960009 219
00643169183704 P960009 219
00763000175719 P960009 219
00643169953703 P960009 219
00643169183704 P960009 219
00613994582454 P960009 219
00643169510487 P960009 220
00643169510487 P960009 220
00643169512917 P960009 229
00643169974821 P960009 229
00643169512917 P960009 229
00643169974821 P960009 229
00643169864238 P960009 243
00643169864238 P960009 243
00643169887473 P960009 265
00643169763289 P960009 265
00643169763289 P960009 265
00643169887497 P960009 265
00643169887473 P960009 265
00643169887497 P960009 265
00643169887442 P960009 266
00643169887442 P960009 266
00763000096335 P960009 284
00763000096335 P960009 284
00643169953673 P960009 294
00643169953642 P960009 294
00643169953574 P960009 294
00643169953574 P960009 294
00643169953642 P960009 294
00643169953673 P960009 294

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