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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
Expedited Review Granted? No
Combination ProductNo
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 S036 S037 
S038 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 
S057 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 S119 S120 S121 S123 
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