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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
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantINSIGHTEC, LTD
4851 LBJ FRWY, STE 400
DALLAS, TX 75244
PMA NumberP040003
Supplement NumberS010
Date Received09/13/2011
Decision Date12/08/2011
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT.
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