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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceEXABLATE 2000 SYSTEM
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Applicant
INSIGHTEC, LTD
4851 lbj frwy, ste 400
dallas, TX 75244
PMA NumberP040003
Date Received01/27/2004
Decision Date10/22/2004
Product Code
NRZ[ Registered Establishments with NRZ ]
Docket Number 05M-0473
Notice Date 11/28/2005
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR THE EXABLATE 2000 SYSTEM. THE DEVICE IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE-OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE. PATIENTS MUST HAVE A UTERINE SIZE OF LESS THAN 24 WEEKS AND HAVE COMPLETED CHILD BEARING.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
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