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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 (Exablate Neuro or the system)
Generic NameMR-guided focused ultrasound system
ApplicantInSightec
5 NAHUM HETH STREET
TIRAT-HACARMET 39120
PMA NumberP150038
Supplement NumberS012
Date Received08/08/2019
Decision Date04/14/2020
Product Code POH 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the Exablate Neuro to introduce software version 7.33, expand the use of the device with an additional Siemens 1.5 Tesla (T) Aera magnetic resonance imaging (MRI) scanner, and addition of a custom 1.5 T receive-only imaging coil for the Exablate 4000 Type 1.1 System and a custom 3.0 T receive-only imaging coil for the Exablate 4000 Type 1.0 System.
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