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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 (DBS)SYSTEM
Classification Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
Applicant
MEDTRONIC NEUROMODULATION
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
Expedited Review Granted? No
Combination ProductNo
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 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S076 S077 S078 S079 S080 S081 
S082 S083 S084 S085 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 S150 S151 S152 S154 
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