This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the precision spinal cord stimulation (scs) system. The device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
| Device | PRECISION SPINAL CORD STIMULATION(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 | 2003-05-14 |
| Decision Date | 2004-04-27 |
| Notice Date | 2004-06-10 |
| PMA | P030017 |
| Supplement | S |
| Product Code | LGW |
| Docket Number | 04M-0256 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 25155 Rye Canyon Loop valencia, CA 91355 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |