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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.
 
DeviceVERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian symptoms
Generic Namestimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP150031
Date Received08/26/2015
Decision Date12/08/2017
Product Code
NHL[ Registered Establishments with NHL ]
Docket Number 17M-6800
Notice Date 12/15/2017
Advisory Committee Neurology
Clinical Trials NCT01221948
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Vercise DBS System. The device is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) in the treatment of patients with moderate to advanced levodopa-responsive Parkinsons disease (PD), which is not adequately controlled with medication.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S005 S006 S007 S008 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S022 S023 
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