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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
Suite 400
Dallas, TX 75244
PMA NumberP040003
Supplement NumberS016
Date Received04/07/2015
Decision Date10/05/2015
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT01285960
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE SOFTWARE OF THE EXABLATE SYSTEM INCLUDING ENABLING MOVEMENT OF THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTION. THE MODIFIED DEVICE IS REFERRED TO AS THE EXABLATE 2100 V1.1 WITH SOFTWARE VERSION 6.5.
Post-Approval StudyShow Report Schedule and Study Progress
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