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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 NumberS005
Date Received03/29/2021
Decision Date04/27/2021
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of additional adverse event information and clarification of troubleshooting instructions to the labeling of the instructions for use (IFU-3243 Rev E).
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