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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
ApplicantInSightec
5 NAHUM HETH STREET
TIRAT-HACARMET 39120
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes to the indications for use of the device in idiopathic Essential tremor patients with medication-refractory tremor.
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