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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.
 
DeviceMinerva Endometrial Ablation System
Generic NameDevice, thermal ablation, endometrial
ApplicantMINERVA SURGICAL
101 SAGINAW DRIVE
REDWOOD CITY, CA 94063
PMA NumberP140013
Supplement NumberS010
Date Received04/09/2018
Decision Date06/21/2018
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for software modifications to the RF controller and the implementation of additional software checks
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