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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.
Generic NameMR-guided focused ultrasound system
PMA NumberP150038
Supplement NumberS006
Date Received03/07/2018
Decision Date12/16/2018
Product Code POH 
Docket Number 19M-4780
Notice Date 01/25/2019
Advisory Committee Neurology
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 Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor. Patients must be at least age 30.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress