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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBRIO NEUROSTIMULATION SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Date Received05/05/2014
Decision Date06/12/2015
Product Codes MHY NHL PJS 
Docket Number 15M-2497
Notice Date 07/10/2015
Advisory Committee Neurology
Clinical TrialsNCT00552474
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE BRIO NEUROSTIMULATION SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING CONDITIONS:1) BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY TO REDUCE SOME OF THE SYMPTOMS OF ADVANCED LEVODOPA-RESPONSIVE PARKINSONS DISEASE THAT ARE NOT ADEQUATELY CONTROLLED BY MEDICATIONS; AND 2) UNILATERAL OR BILATERAL STIMULATION OF THE VENTRAL INTERMEDIATE NUCLEUS (VIM) OF THE THALAMUS FOR THE SUPPRESSION OF DISABLING UPPER EXTREMITY TREMOR IN ADULT ESSENTIALTREMOR PATIENTS WHOSE TREMOR IS NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S074 S076 S029 S030 S056 S057 S058 S059 S060 S024 S025 S023 
S020 S021 S022 S014 S015 S012 S013 S001 S002 S003 S004 S005 
S006 S007 S008 S009 S010 S011  S079 S080 S069 S070 S016 
S017 S019 S040 S061 S062 S063 S047 S051 S044 S045 S055 S082 
S086 S087 S088 S089 S098 S108 S109 S110 S091 S092 S027 S028 
S033 S034 S035 S036 S038 S031 S032 S041 S042 S039 S037 S048 
S049 S052 S053 S064 S050 S043 S054 S046 S077 S078 S066 S067 
S083 S065 S071 S072 S068 S075 S073 S081 S090 S102 S103 S104 
S105 S106 S107 S093 S094 S095 S096 S097 S111 S112 S113 S114 
S115 S116 S117 S099 S100 S101 S084 S085 
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