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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DevicePRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Date Received05/14/2003
Decision Date04/27/2004
Product Code LGW 
Docket Number 04M-0256
Notice Date 06/10/2004
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S139 S140 S203 S204 S205 S186 S188 S187 S158 S159 S160 S161 
S162 S146 S211 S212 S213 S182 S183 S184 S185 S166 S165 S167 
S168 S196 S197 S198 S199 S200 S201 S226 S227 S228 S129 S130 
S131 S004 S006 S022 S023 S024 S025 S001 S002 S003 S067 S098 
S099 S054 S055 S057 S059 S060 S061 S062 S065 S026 S028 S029 
S030 S110 S104 S105 S106 S010 S011 S015 S244 S245 S255 S269 
S270 S271 S272 S273 S274 S275 S276 S289 S290  S125 S178 
S179 S181 S189 S190 S229 S230 S231 S147 S148 S151 S152 S153 
S154 S155 S156 S214 S215 S216 S217 S218 S219 S220 S141 S142 
S143 S144 S145 S163 S164 S202 S243 S132 S133 S134 S135 S136 
S137 S138 S126 S127 S128 S206 S207 S208 S209 S210 S232 S233 
S234 S235 S236 S169 S170 S171 S172 S173 S174 S191 S192 S193 
S194 S195 S221 S222 S223 S224 S157 S175 S176 S177 S007 S008 
S012 S013 S014 S031 S032 S033 S034 S035 S037 S039 S040 S041 
S042 S045 S046 S047 S048 S049 S050 S052 S053 S094 S095 S107 
S108 S109 S069 S071 S072 S073 S074 S075 S076 S077 S079 S080 
S081 S082 S083 S084 S085 S086 S087 S088 S090 S091 S016 S017 
S018 S019 S020 S021 S092 S100 S101 S102 S103 S096 S093 S246 
S247 S248 S260 S261 S262 S263 S264 S249 S250 S251 S296 S297 
S298 S299 S300 S252 S253 S254 S277 S278 S279 S280 S281 S282 
S283 S284 S285 S286 S287 S288 S265 S266 S267 S268 S256 S257 
S258 S259 S291 S292 S293 S294 S295 S315 S316 S317 S302 S326 
S341 S342 S328 S320 S321 S334 S335 S336 S337 S338 S352 S346 
S350 S347 S348 S305 S306 S307 S311 S301 S318 S308 S309 S310 
S303 S304 S312 S313 S314 S322 S323 S327 S319 S331 S332 S339 
S340 S329 S330 S333 S324 S325 S351 S360 S361 S362 S363 S364 
S353 S354 S355 S356 S357 S358 S359 S365 S366 S349 S343 S344 
S345 S368 S369 S370 S372 S373 S367 S111 S112 S113 S114 S115 
S116 S117 S118 S119 S120 S121 S123 S124 S237 S238 S239 S240 
S241 S242 
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