• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Applicant
Boston 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 Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S028 S029 
S030 S031 S032 S033 S034 S035 S037 S039 S040 
S041 S042 S045 S046 S047 S048 S049 S050 S052 
S053 S054 S055 S057 S059 S060 S061 S062 S065 
S067 S069 S071 S072 S073 S074 S075 S076 S077 
S079 S080 S081 S082 S083 S084 S085 S086 S087 
S088 S090 S091 S092 S093 S094 S095 S096 S098 
S099 S100 S101 S102 S103 S104 S105 S106 S107 
S108 S109 S110 S111 S112 S113 S114 S115 S116 
S117 S118 S119 S120 S121 S123 S124 S125 S126 
S127 S128 S129 S130 S131 S132 S133 S134 S135 
S136 S137 S138 S139 S140 S141 S142 S143 S144 
S145 S146 S147 S148 S151 S152 S153 S154 S155 
S156 S157 S158 S159 S160 S161 S162 S163 S164 
S165 S166 S167 S168 S169 S170 S171 S172 S173 
S174 S175 S176 S177 S178 S179 S181 S182 S183 
S184 S185 S186 S187 S188 S189 S190 S191 S192 
S193 S194 S195 S196 S197 S198 S199 S200 S201 
S202 S203 S204 S205 S206 S207 S208 S209 S210 
S211 S212 S213 S214 S215 S216 S217 S218 S219 
S220 S221 S222 S223 S224 S226 S227 S228 S229 
S230 S231 S232 S233 S234 S235 S236 S237 S238 
S239 S240 S241 S242 S243 S244 S245 S246 S247 
S248 S249 S250 S251 S252 S253 S254 S255 S256 
S257 S258 S259 S260 S261 S262 S263 S264 S265 
S266 S267 S268 S269 S270 S271 S272 S273 S274 
S275 S276 S277 S278 S279 S280 S281 S282 S283 
S284 S285 S286 S287 S288 S289 S290 S291 S292 
S293 S294 S295 S296 S297 S298 S299 S300 S301 
S302 S303 S304 S305 S306 S307 S308 S309 S310 
S311 S312 S313 S314 S315 S316 S317 S318 S319 
S320 S321 S322 S323 S324 S325 S326 S327 S328 
S329 S330 S331 S332 S333 S334 S335 S336 S337 
S339 S340 S341 
-
-