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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.
 
DeviceCerene Cryotherapy Device
Generic NameDevice, thermal ablation, endometrial
ApplicantChannel Medsystems, Inc.
5858 Horton Street, Suite 200
Emeryville, CA 94608
PMA NumberP180032
Supplement NumberS006
Date Received06/30/2021
Decision Date08/27/2021
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 a design change to the Inflow Solenoid, miniature solenoid valve, and miniature solenoid valve gasket.
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