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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 1.0 and 1.1 System (“Exablate Neuro”)
Generic NameMR-guided focused ultrasound system
ApplicantInSightec
5 NAHUM HETH STREET
TIRAT-HACARMET 39120
PMA NumberP150038
Supplement NumberS014
Date Received03/31/2021
Decision Date10/29/2021
Product Code POH 
Docket Number 21M-1182
Notice Date 11/03/2021
Advisory Committee Neurology
Clinical TrialsNCT03319485
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Exablate Neuro. The device is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinsons disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (GPi)] must be identified and accessible for targeted thermal ablation by the Exablate device.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
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