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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 supplement. The device description may have changed. Be sure to look at the original PMA 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, INC.
PMA NumberP040003
Supplement NumberS005
Date Received09/19/2008
Decision Date03/04/2009
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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 per-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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