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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCerene® Cryotherapy Device
Generic NameDevice, thermal ablation, endometrial
ApplicantChannel Medsystems, Inc.
5858 Horton St., Suite 200
Emeryville, CA 94608
PMA NumberP180032
Date Received08/13/2018
Decision Date03/28/2019
Product Code MNB 
Docket Number 19M-1506
Notice Date 03/29/2019
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT02842736
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Cerene® Cryotherapy Device. This device is indicated for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S018 S001 S012 S004 S013  S011 S005 S009 S014 
S010 S006 S007 S008 S019 S020 S021 S016 S015 S022 
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