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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 NameITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namespinal cord stimulator system
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP840001
Date Received01/13/1984
Decision Date11/30/1984
Product Code
LGW[ Registered Establishments with LGW ]
Docket Number 84M-0415
Notice Date 01/02/1985
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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S039 S040 S041 S042 S043 S044 S045 S046 S047 
S049 S050 S051 S052 S053 S054 S055 S058 S059 
S060 S061 S062 S063 S064 S065 S066 S067 S068 
S069 S070 S071 S072 S073 S074 S075 S076 S077 
S080 S081 S082 S083 S084 S086 S088 S089 S090 
S091 S092 S093 S095 S096 S097 S098 S099 S100 
S101 S102 S103 S104 S105 S106 S107 S108 S109 
S110 S111 S112 S113 S114 S115 S117 S118 S119 
S121 S122 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 S149 S150 S151 S152 S153 S154 S155 S156 
S157 S158 S159 S160 S161 S162 S163 S164 S165 
S167 S168 S169 S170 S171 S172 S173 S174 S175 
S176 S178 S179 S180 S181 S182 S183 S184 S185 
S186 S187 S188 S189 S190 S191 S192 S193 S194 
S195 S196 S197 S198 S199 S200 S201 S202 S203 
S205 S206 S207 S208 S209 S210 S211 S212 S213 
S214 S215 S216 S217 S218 S219 S220 S221 S222 
S223 S224 S225 S226 S227 S228 S229 S230 S231 
S232 S233 S234 S235 S237 S239 S240 S241 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 S274 S275 S276 S277 S278 S279 S280 
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