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.
| Device | Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp |
| Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Applicant | Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS359 Date Received12/28/2022 Decision Date01/04/2023 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-28 |
| Decision Date | 2023-01-04 |
| PMA | P030017 |
| Supplement | S359 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 25155 Rye Canyon Loop valencia, CA 91355 PMA NumberP030017 Supplement NumberS359 Date Received12/28/2022 Decision Date01/04/2023 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Use Existing Equipment At The BSC Dorado Facility To Perform The Laser Ablation On The Multi-lumen Tubes Used In The Assembly Of The D4 And W4 2x4 Splitters, 2x8 Splitters, And M1 Connectors Used In The SCS Systems |
| 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 |