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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 DEVICE
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC, LTD
PMA NumberP040003
Supplement NumberS011
Date Received04/09/2012
Decision Date05/01/2012
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes including: 1) deletion of the comment (outcomes of 10 pregnancies are pending as of august 2008, and outcome of one pregnancy is unknown. ) and addition of deep vein thrombosis under the section entitled other adverse events.
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