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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameBRIO NEUROSTIMULATION SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
ApplicantST. JUDE MEDICAL NEUROMODULATION
PMA NumberP140009
Date Received05/05/2014
Decision Date06/12/2015
Product Code
MHY[ Registered Establishments with MHY ]
Docket Number 15M-2497
Notice Date 07/10/2015
Advisory Committee Neurology
Clinical Trials NCT00552474
NCT02087046
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.
Approval Order Approval Order
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