This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the precisio s8 adapter that will be used to connect the precision implantable pulse generator (ipg) or the precision spectra ipg to the following st. Jude medical (sjm) scs leads: 3283/3286/3268/3269 lamitrode s8, 3280 lamitrode 8, 3244/3262/3263 lamitrode 44, 3245/3264/3265 lamitrode 44c, 3208 lamitrode tripole 8, 3210lamitrode tripole 8c, 3288 lamitrode 88, 3289 lamitrode 88c, 3214 lamitrode tripole 16c, 3219 lamitrode tripole 16, 3228 penta, 3183/3186/3189/3191 octrode, 3086 octrode trial lead kit, 2283 8-channel adapter, 3341/3342/ 3343/3346 dual 4 extension, 3382/3383/3386single 8 extension.
Device | PRECISION SPINAL CORD STIMULATOR(SCS) SYSTEM AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM |
Classification Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
Applicant | Boston Scientific Corp. |
Date Received | 2014-11-24 |
Decision Date | 2015-02-13 |
PMA | P030017 |
Supplement | S210 |
Product Code | LGW |
Advisory Committee | Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 25155 Rye Canyon Loop valencia, CA 91355 |
Supplement Number | Date | Supplement Type |
---|---|---|
P030017 | Original Filing | |
S359 | 2022-12-28 | 30-day Notice |
S358 | ||
S357 | ||
S356 | 2022-12-08 | 30-day Notice |
S355 | 2022-12-07 | 30-day Notice |
S354 | ||
S353 | ||
S352 | 2022-11-14 | 30-day Notice |
S351 | ||
S350 | 2022-06-13 | 30-day Notice |
S349 | 2021-11-15 | 30-day Notice |
S348 | ||
S347 | 2021-09-13 | 30-day Notice |
S346 | 2021-05-24 | 30-day Notice |
S345 | 2021-05-07 | 30-day Notice |
S344 | ||
S343 | 2021-04-19 | 30-day Notice |
S342 | 2020-08-31 | 30-day Notice |
S341 | 2020-08-27 | 30-day Notice |
S340 | 2020-07-13 | 30-day Notice |
S339 | 2020-05-22 | 30-day Notice |
S338 | ||
S337 | 2020-04-20 | 30-day Notice |
S336 | 2020-04-17 | 30-day Notice |
S335 | 2020-03-27 | 30-day Notice |
S334 | 2020-03-19 | 30-day Notice |
S333 | 2020-02-20 | 30-day Notice |
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 |