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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.
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
PMA NumberP040003
Supplement NumberS010
Date Received09/13/2011
Decision Date12/08/2011
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the exablate platform 1) so that the same platform can be used with multiple cradles; and 2) to enable the cradle that has the capability to move the transducer in the anterior and posterior directions be used in the locked position for commercial uterine fibroid treatment.