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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
Classification Namemr-guided focused ultrasound system
Generic Namemr-guided focused ultrasound system
Applicant
InSightec
5 nahum heth street
tirat-hacarmet 39120
PMA NumberP150038
Date Received10/21/2015
Decision Date07/11/2016
Product Code
POH[ Registered Establishments with POH ]
Docket Number 16M-2183
Notice Date 07/25/2016
Advisory Committee Neurology
Clinical Trials NCT01827904
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 
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