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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXABLATE 2000
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantINSIGHTEC, LTD
4851 LBJ FRWY, STE 400
DALLAS, TX 75244
PMA NumberP040003
Supplement NumberS002
Date Received07/17/2006
Decision Date02/27/2007
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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