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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.
 
DeviceINSIGHTEC EXABLATE SYSTEM
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP110039
Supplement NumberS001
Date Received11/06/2012
Decision Date03/15/2013
Product Code NRZ 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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