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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 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec, Ltd.
4851 Lbj Frwy
Suite 400
Dallas, TX 75244
PMA NumberP040003
Supplement NumberS022
Date Received06/25/2025
Decision Date07/23/2025
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
You proposed to change the total number of enrolled subjects from 200 to 198. Based upon the information submitted, the PMA supplement is approved.
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