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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.
 
Trade NameMEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY
Classification Namedeep brain stimulator for obsessive compulsive disorder (ocd)
Generic Namedeep brain stimulator for obsessive compulsive disorder (ocd)
Applicant
MEDTRONIC INC.,NEUROLOGICAL DIVISION
7000 central avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Date Received10/31/2005
Decision Date02/10/2009
Product Code
OLM[ Registered Establishments with OLM ]
Docket Number 09M-0090
Advisory Committee Neurology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
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 
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