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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.
 
Trade NameEXABLATE 2000 SYSTEM
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC, LTD
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 
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