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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.
 
Trade NamePRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantBOSTON SCIENTIFIC CORP.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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 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 
S187 S188 S189 S190 
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