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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.
 
DeviceEXABLATE 2000/2100 1.5 AND 3T
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Applicant
INSIGHTEC, LTD
4851 lbj frwy, ste 400
dallas, TX 75244
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 change - pas
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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