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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
Applicant
Abbott Medical
6901 prestion road
plano, TX 75024
PMA NumberP140009
Date Received05/05/2014
Decision Date06/12/2015
Product Codes MHY  PJS  NHL 
Docket Number 15M-2497
Notice Date 07/10/2015
Advisory Committee Neurology
Clinical Trials NCT00552474
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S012 S013 S014 S015 S016 S017 
S019 S020 S021 S022 S023 S024 S025 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 S054 S055 S056 
S057 S058 S059 S060 S061 S063 
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