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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
Applicant
Channel Medsystems, Inc.
5858 horton street, suite 200
emeryville, CA 94608
PMA NumberP180032
Supplement NumberS002
Date Received10/21/2020
Decision Date11/18/2020
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 Product No
Approval Order Statement 
Approval of labeling changes to improve safety information related to EMC and electrical safety.
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