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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 2000/2100
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP110039
Supplement NumberS004
Date Received09/23/2013
Decision Date12/17/2013
Product Code NRZ 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR.
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