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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 SYSTEM
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 NumberS012
Date Received08/13/2012
Decision Date09/07/2012
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE MANUFACTURING OF THE TRANSDUCER FOR THE EXABLATE SYSTEM FROM A CONTRACT MANUFACTURER TO THE IN-HOUSE FACILITY.
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