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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 IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP010013
Supplement NumberS047
Date Received07/26/2013
Decision Date04/25/2014
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 DECREASED OUTER SHEATH DIAMETER, MODIFICATION OF THE CERVICAL SEAL DESIGN, AND CHANGE IN THE FRONT HANDLE COLOR.
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