Cerene Cryotherapy

FDA Premarket Approval P180032 S001

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 changes to the specifications of the device including the upper limit of the amount of n2o delivered, the operating temperature range, and the parameter range of initiating a fault, as well as changes to lcd prompts, the venting mechanism, hardware, tray packaging, software, and contractors for sterilizing, packaging, and labeling.

DeviceCerene Cryotherapy
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantChannel Medsystems, Inc.
Date Received2020-01-03
Decision Date2020-07-08
PMAP180032
SupplementS001
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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