PMA P180032S023

Device: Cerene® Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S023
Product code: MNB
Decision date: 2026-07-08
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: The recommended decision for this file is Approve PMA GMP without inspection. This recommendation is based on transferring a low-risk labeling activity to a manufacturing site (and sponsor) previously approved under the PMA.

Current openFDA PMA Record#

Device: Cerene® Cryotherapy Device
Applicant: Channel Medsystems, Inc.
PMA number: P180032
Supplement: S023
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2026-07-08
Decision code: APPR
Date received: 2026-06-12
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The recommended decision for this file is Approve PMA GMP without inspection. This recommendation is based on transferring a low-risk labeling activity to a manufacturing site (and sponsor) previously approved under the PMA.