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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 NumberS008
Date Received07/01/2021
Decision Date07/26/2021
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
Approval Order Statement  
Modification to the manufacturing procedure for the subject device. This change is the implementation of a Desco Ionizing Fan into the tray sealing process to replace the ionizing air gun that is currently used.
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