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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 NumberS010
Date Received05/02/2022
Decision Date05/31/2022
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the modification to the manufacturing process for the subject device. This change is the addition of an inspection step made to the manufacturing process to verify that the control software has been successfully loaded onto the device.
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