Precision Spinal Cord Stimulator (SCS) Systems

FDA Premarket Approval P030017 S341

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.

Pre-market Approval Supplement Details

Implementation of an alternate cleaning agent

DevicePrecision Spinal Cord Stimulator (SCS) Systems
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantBoston Scientific Corp.
Date Received2020-08-27
Decision Date2020-09-22
PMAP030017
SupplementS341
Product CodeLGW 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 25155 Rye Canyon Loop valencia, CA 91355

Supplemental Filings

Supplement NumberDateSupplement Type
P030017Original Filing
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

NIH GUDID Devices

Device IDPMASupp
08714729982579 P030017 323
08714729990376 P030017 326
08714729991274 P030017 331
08714729991281 P030017 331
08714729991373 P030017 331
08714729991212 P030017 331
08714729991229 P030017 331
08714729991366 P030017 331
08714729991380 P030017 331
08714729991267 P030017 331

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