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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
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantINSIGHTEC, LTD
4851 LBJ FRWY, STE 400
DALLAS, TX 75244
PMA NumberP040003
Supplement NumberS005
Date Received09/19/2008
Decision Date03/04/2009
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING AND TREATMENT PROTOCOL CHANGES. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME EXABLATE 2000 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. LIMITED INFORMATION IS AVAILABLE REGARDING THE SAFETY AND EFFECTIVENESS OF THE EXABLATE AS A TREATMENT FOR WOMEN WHO DESIRE PREGNANCY. PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.
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