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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 St., Suite 200
Emeryville, CA 94608
PMA NumberP180032
Supplement NumberS015
Date Received10/23/2023
Decision Date11/16/2023
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes that add and/or strengthen instructions that are intended to enhance the safe use of the device.
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