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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
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP150031
Date Received08/26/2015
Decision Date12/08/2017
Product Code NHL 
Docket Number 17M-6800
Notice Date 12/15/2017
Advisory Committee Neurology
Clinical TrialsNCT01221948
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S005 S006 S007 S008 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S026 
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 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 
S063 S066 S067 S069 
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