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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
Generic NameMR-guided focused ultrasound system
ApplicantInSightec
5 NAHUM HETH STREET
TIRAT-HACARMET 39120
PMA NumberP150038
Supplement NumberS034
Date Received01/29/2024
Decision Date02/27/2024
Product Code POH 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
a change of the manufacturing method for the head membrane rings from computer numerical control (CNC) machining to molding, and the manufacturing method of attaching the rings to head membrane was changed from screws to over-molding
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