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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 & Type 1.1 System (“Exablate Neuro”)
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Supplement NumberS033
Date Received11/22/2023
Decision Date01/21/2024
Product Code POH 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at R.H. Electronics Ltd., 5 Hatzoref St. Har-Yona Industrial Area, Nof Hagalil, Nazereth Illit, 17000, Israel, for assembly activities of the Exablate Neuro treatment kits
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