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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 2100 SYSTEM
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec, Ltd.
4851 Lbj Frwy
Suite 400
Dallas, TX 75244
PMA NumberP040003
Supplement NumberS006
Date Received06/05/2009
Decision Date12/22/2009
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT00365989
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 ADDITION OF ENHANCED SONICATION, A DETACHABLE CRADLE, AND SEVERAL OTHER MODIFICATIONS TO THE EXABLATE 2000 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE 2100 AND IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE- OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS. PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.
Post-Approval StudyShow Report Schedule and Study Progress
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