Cerene® Cryotherapy

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P180032

Pre-market Approval Supplement Details

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.

DeviceCerene® Cryotherapy
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantChannel Medsystems, Inc.
Date Received2018-08-13
Decision Date2019-03-28
PMAP180032
SupplementS
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Expedited ReviewNo
Combination Product No
Applicant Address Channel Medsystems, Inc. 5858 Horton Street, Suite 200 emeryville, CA 94608
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P180032Original Filing
S009 2021-08-09 30-day Notice
S008 2021-07-01 30-day Notice
S007 2021-06-30 30-day Notice
S006
S005 2021-03-29 Special (immediate Track)
S004 2021-02-01 30-day Notice
S003 2020-10-29 Normal 180 Day Track No User Fee
S002 2020-10-21 Special (immediate Track)
S001 2020-01-03 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00850008595035 P180032 001
20850008595022 P180032 001

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