PMA P180032S010

Device: Cerene Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S010
Product code: MNB
Decision date: 2022-05-31
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for the modification to the manufacturing process for the subject device. This change is the addition of an inspection step made to the manufacturing process to verify that the control software has been successfully loaded onto the device.

Current openFDA PMA Record#

Device: Cerene Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S010
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2022-05-31
Decision code: APPR
Date received: 2022-05-02
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the modification to the manufacturing process for the subject device. This change is the addition of an inspection step made to the manufacturing process to verify that the control software has been successfully loaded onto the device.