Cerene Cryotherapy

FDA Premarket Approval P180032 S008

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 modification to the manufacturing procedure for the subject device. This change is the implementation of a desco ionizing fan into the tray sealing process to replace the ionizing air gun that is currently used

DeviceCerene Cryotherapy
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantChannel Medsystems, Inc.
Date Received2021-07-01
Decision Date2021-07-26
PMAP180032
SupplementS008
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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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