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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 NumberS001
Date Received01/03/2020
Decision Date07/08/2020
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT02842736
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the specifications of the device including the upper limit of the amount of N2O delivered, the operating temperature range, and the parameter range of initiating a fault, as well as changes to LCD prompts, the venting mechanism, hardware, tray packaging, software, and contractors for sterilizing, packaging, and labeling.
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