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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 Endometrail Ablation Device
Generic NameDevice, thermal ablation, endometrial
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP010013
Supplement NumberS070
Date Received04/19/2018
Decision Date05/17/2018
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of the second supplier for the Thumb Pusher Component of the Novasure Disposable Device and the addition of the second supplier for the CO2 Cartridge 5-Pack Assembly.
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