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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.
 
DeviceNOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT
Generic NameDevice, thermal ablation, endometrial
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP010013
Supplement NumberS051
Date Received10/17/2013
Decision Date04/22/2014
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE NOVASURE RADIOFREQUENCY CONTROLLER (RFC) TO INCORPORATE A SOFTWARE-BASED GRAPHICAL USER INTERFACE (GUI), RESULTING IN THE MODEL 10 RFC.
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