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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: S158 S159 S160 S161 S162 S120 S121 S123 S124  S226 S227 
S228 S211 S212 S213 S139 S140 S001 S002 S003 S186 S188 S187 
S132 S133 S134 S135 S136 S137 S138 S125 S196 S197 S175 S176 
S177 S237 S238 S239 S240 S241 S242 S203 S204 S205 S146 S022 
S023 S024 S025 S098 S067 S015 S054 S055 S057 S059 S060 S061 
S062 S065 S026 S028 S029 S030 S010 S011 S007 S008 S244 S245 
S255 S269 S270 S271 S272 S273 S274 S275 S276 S289 S290 S116 
S117 S118 S119 S130 S131 S141 S142 S143 S144 S145 S147 S148 
S151 S152 S153 S154 S163 S164 S178 S179 S229 S230 S231 S198 
S199 S200 S201 S202 S214 S215 S216 S217 S218 S219 S220 S189 
S190 S166 S165 S167 S168 S181 S182 S183 S184 S185 S243 S206 
S207 S208 S209 S210 S232 S233 S234 S235 S236 S126 S127 S128 
S129 S155 S156 S157 S221 S222 S223 S224 S191 S192 S193 S194 
S195 S113 S114 S115 S012 S013 S014 S031 S032 S033 S034 S035 
S037 S039 S040 S041 S042 S045 S046 S047 S048 S049 S050 S052 
S053 S016 S017 S094 S095 S099 S100 S107 S108 S109 S069 S071 
S072 S073 S074 S075 S076 S077 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 S090 S091 S004 S006 S092 S101 S102 S103 
S096 S110 S111 S112 S018 S019 S020 S021 S093 S104 S105 S106 
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 S169 S170 S171 S172 
S173 S174 S311 S315 S316 S317 S302 S327 S333 S325 S326 S341 
S342 S329 S330 S352 S346 S350 S347 S348 S305 S306 S307 S301 
S308 S318 S319 S312 S313 S314 S309 S310 S303 S304 S320 S321 
S328 S334 S335 S322 S323 S324 S331 S332 S336 S337 S338 S339 
S340 S351 S360 S361 S362 S363 S364 S353 S354 S355 S356 S357 
S358 S359 S367 S343 S344 S345 S349 S368 S369 S370 S365 S366 
S372 S373 
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