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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Date Received05/14/2003
Decision Date04/27/2004
Product Code
LGW[ Registered Establishments with 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 
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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 
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S090 S091 S092 S093 S094 S095 S096 S098 S099 
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S109 S110 S111 S112 S113 S114 S115 S116 S117 
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S128 S129 S130 S131 S132 S133 S134 S135 S136 
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S146 S147 S148 S151 S152 S153 S154 S155 S156 
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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 
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