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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 SYSTEM
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec, Ltd.
4851 Lbj Frwy
Suite 400
Dallas, TX 75244
PMA NumberP040003
Supplement NumberS018
Date Received05/10/2016
Decision Date08/26/2016
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS).
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