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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 2100 SYSTEM
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC, INC.
PMA NumberP040003
Supplement NumberS006
Date Received06/05/2009
Decision Date12/22/2009
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Clinical Trials NCT00365989
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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