PMA P180032S008

Device: Cerene Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S008
Product code: MNB
Decision date: 2021-07-26
Generic name: Device, thermal ablation, endometrial
Approval order statement: 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.

Current openFDA PMA Record#

Device: Cerene Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S008
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2021-07-26
Decision code: OK30
Date received: 2021-07-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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.