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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 Neuro Thalamotomy
Generic Namemr-guided focused ultrasound system
Applicant
InSightec
5 nahum heth street
tirat-hacarmet 39120
PMA NumberP150038
Supplement NumberS004
Date Received08/16/2017
Decision Date10/13/2017
Product Code POH 
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised protocol for the post-approval study (PAS) protocol.
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