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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 NumberS003
Date Received10/29/2020
Decision Date02/25/2021
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of information from the post-approval study to the patient labeling and instructions for use
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