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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
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
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
Supplements: S002 S003 S006 S007