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 addition of an alternate ethylene oxide sterilization site at the boston scientific clonmel manufacturing site at cashel road, clonmel, co. Tipperary, ireland and new sterilization cycle parameters for that facility.
| Device | Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulato |
| 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 | 2017-05-30 |
| Decision Date | 2017-11-22 |
| PMA | P030017 |
| Supplement | S295 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |