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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
Applicant
Channel Medsystems, Inc.
5858 horton street, 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 Trials NCT02842736
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S004 S002 S003 S001 
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