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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceExablate Model 4000 Type-1 System
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Supplement NumberS037
Date Received07/16/2024
Decision Date07/03/2025
Product Code POH 
Docket Number 25M-2196
Notice Date 07/10/2025
Advisory Committee Neurology
Clinical TrialsNCT04728295
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson’s Disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinson’s disease medication treatment, and in the staged (by at least 6 months from the first pallidothalamic tractotomy), unilateral pallidothalamic tractotomy of idiopathic Parkinson’s Disease with medication-refractory motor complications of their contralateral side that was not previously treated in the first unilateral pallidothalamic tractotomy. Patients must be at least age 30. The designated area in the brain responsible for the motor complications symptoms (pallidothalamic tract) must be identified and accessible for targeted thermal ablation by the Exablate device.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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