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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
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC
PMA NumberP040003
Supplement NumberS002
Date Received07/18/2006
Decision Date02/27/2007
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement the version 4. 2 software and a new patient table (with other related hardware) that allow for operation of the exablate 2000 system with the general electric 3t magnetic resonance imaging (mri) system. Version 4. 2 software provides for an interleaved mode of operation, elongated focal spots, and a scale-able cooling during.
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