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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 4000 System Type-1 (i.e. Type 1.0/1.1)
Generic NameMR-guided focused ultrasound system
PMA NumberP150038
Supplement NumberS022
Date Received06/14/2022
Decision Date12/08/2022
Product Code POH 
Advisory Committee Neurology
Clinical TrialsNCT04112381
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling changes to the indications for use of the device in idiopathic Essential tremor patients with medication-refractory tremor.