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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 2000/2100 1.5 AND 3T
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC, LTD
PMA NumberP040003
Supplement NumberS009
Date Received07/26/2010
Decision Date08/09/2011
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updated labeling including long-term data from the post-approval study.
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