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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.
 
DeviceEXABLATE
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Date Received10/21/2015
Decision Date07/11/2016
Product Code POH 
Docket Number 16M-2183
Notice Date 07/25/2016
Advisory Committee Neurology
Clinical TrialsNCT01827904
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the ExAblate Model 4000 Type 1.0 System (ExAblate Neuro). This device is indicated for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the ExAblate device.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S003 S001 S002 S004 S005 S006 S023 S026 S019 S020 S021 
S032 S008 S007 S011 S012 S013 S009 S010 S024 S033 S022 S014 
S015 S018 S025 S038 S039 S040 S034 S035 S037 S041 S036 S027 
S028 S029 S030 S031 S042 S043 
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