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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
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 S151 S153 S154 S155 
S156 S158 S159 S160 S162 
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