PMA P180032S020

Device: Cerene Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S020
Product code: MNB
Decision date: 2024-12-12
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for the change to sterilization methods to allow the Cerene Cryotherapy Device to be sterilized up to two times with ethylene oxide (2X EO).

Current openFDA PMA Record#

Device: Cerene Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S020
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2024-12-12
Decision code: APPR
Date received: 2024-09-19
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the change to sterilization methods to allow the Cerene Cryotherapy Device to be sterilized up to two times with ethylene oxide (2X EO).