Cerene® Cryotherapy

FDA Premarket Approval P180032 S005

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.

Pre-market Approval Supplement Details

Approval for the addition of additional adverse event information and clarification of troubleshooting instructions to the labeling of the instructions for use (ifu-3243 rev e).

DeviceCerene® Cryotherapy
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantChannel Medsystems, Inc.
Date Received2021-03-29
Decision Date2021-04-27
PMAP180032
SupplementS005
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Channel Medsystems, Inc. 5858 Horton Street, Suite 200 emeryville, CA 94608

Supplemental Filings

Supplement NumberDateSupplement Type
P180032Original Filing
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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