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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 NumberS009
Date Received01/31/2018
Decision Date05/01/2018
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 the co-packaging of the Minerva Cervical Dilator with the Minerva Disposable Handpiece, modifications to the packaging design to accommodate said co-packaging, and the addition of a manufacturing supplier for the thermoformed tray and insert used in packaging said co-packaged devices.
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