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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 and 1.1 Systems (“Exablate Neuro”)
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Supplement NumberS026
Date Received04/11/2023
Decision Date03/25/2025
Product Code POH 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change to the prescriber’s labeling to include the post-approval study (PAS) results from the 5-year follow-up of the continued access cohort (ET002-CA) evaluated under investigational device exemption (IDE) G120246/S007 to continue use of the Exablate Neuro while the original PMA P150038 application was being reviewed by the FDA
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