Humanitarian Device Exemption (HDE)

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 Name: MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY
• Classification Name: deep brain stimulator for obsessive compulsive disorder (ocd)
• Generic Name: deep brain stimulator for obsessive compulsive disorder (ocd)
• Applicant: MEDTRONIC INC.,NEUROLOGICAL DIVISION; 7000 central avenue northeast; minneapolis, MN 55432
• HDE Number: H050003
• Date Received: 10/31/2005
• Decision Date: 02/10/2009
• Product Code: OLM [ Registered Establishments with OLM ]
• Docket Number: 09M-0090
• Advisory Committee: Neurology
• Supplement Type: hde original
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the reclaim dbs therapy for obsessive compulsive disorder (ocd). This device is indicated for bilateral stimulation of the anterior limb of the internal capsule, aic, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (ocd) in adult patients who have failed at least three selective serotonin reuptake inhibitors (ssris).

Approval Order

Approval Order

Summary

Summary of Safety And Probable Benefit

Labeling

Labeling
Labeling Part 2

• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 ; S010 S011 S012 S013 S014 S015 S016 S017 S018 ; S019 S020 S021 S022 S023 S024 S025 S026 S027 ; S028 S029 S030 S031 S032 S033 S034 S035 S036 ; S037 S038 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 S222 S223 S224 S225 S226 S227 ; S228 S229 S230 S231 S232 S233 S234 S235 S236 ; S237 S238 S239 S241 S242 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 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 S322 S323 S325 S327 S335