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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceCerene® Cryotherapy Device
Classification Namedevice, thermal ablation, endometrial
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[ Registered Establishments with 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
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