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.

Device	VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Generic Name	Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant	Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355
PMA Number	P150031
Date Received	08/26/2015
Decision Date	12/08/2017
Product Code	NHL
Docket Number	17M-6800
Notice Date	12/15/2017
Advisory Committee	Neurology
Clinical Trials	NCT01221948
Expedited Review Granted?	No
Combination Product	No
Recalls	CDRH 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 Order	Approval Order
Summary	Summary of Safety and Effectiveness
Labeling	Labeling Labeling Part 2
Supplements:	S005 S007 S020 S029 S017 S018 S019 S038 S023 S024 S026  S048 S051 S043 S050 S055 S040 S044 S045 S046 S008 S006 S001  S002 S003 S010 S021 S022 S030 S011 S012 S013 S014 S015 S016  S027 S031 S032 S033 S034 S035 S036 S037 S028 S056 S057 S058  S059 S052 S053 S054 S049 S062 S063 S064 S039 S041 S042 S047  S067 S069 S060 S061 S070 S071 S066