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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
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Supplement NumberS007
Date Received04/23/2018
Decision Date05/09/2018
Product Code POH 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Consolidate the two connector types of the 1.5T Head Coil cables into a single connector type (P-Type). The change is being made to maintain compatibility with the GE Medical Systems (GE) Signa Artist MR scanner.
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