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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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 Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
7000 central avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Date Received11/27/2002
Decision Date04/15/2003
Product Code
MRU[ Registered Establishments with MRU ]
Docket Number 03M-0157
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the medtronic activa@ dystonia therapy which includes the model 3307 activao dystonia therapy kit, the model 3309 activa" dystonia therapy kit and associated products. This device is indicated for unilateral or bilateral stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S006 S008 S010 S011 S013 S014 
S015 S016 S017 S018 S021 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S043 S044 
S045 S046 S047 S048 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 
S072 S073 S074 S075 S076 S077 S078 S079 S080 
S081 S082 S083 S084 S085 S086 S087 S088 S089 
S090 S091 S092 S093 S094 S095 S096 S097 S098 
S099 S100 S101 S102 S103 S104 S105 S106 S107 
S108 S109 S110 S111 S112 S113 S114 S115 S116 
S117 S118 S119 S120 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 S166 S167 S168 S169 S170 
S171 S172 S173 S174 S175 S176 S177 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 S204 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 S236 S237 S238 S239 S240 S241 S242 
S243 S244 S245 S246 S247 S248 S249 S250 S251 
S253 S254 S255 S256 S257 S258 S259 S260 S261 
S262 S263 S264 S265 S266 S267 S268 S269 S270 
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 S338 S339 S340 S341 S342 S343 
S344 S345 S346 S347 S348 S349 S350 S351 S352 
S353 S354 S355 S356 S357 S358 S359 S360 S361 
S362 S363 S365 S366 S367 S369