Cerene® Cryotherapy Device

FDA premarket approval P180032 · Device, thermal ablation, endometrial

PMA numberP180032

Approval

Applicant
Channel Medsystems, Inc.
Received
August 13, 2018
Decision date
March 28, 2019 (APPR)
Supplements
22, latest July 8, 2026
Product code
MNB – Device, Thermal Ablation, Endometrial

Official FDA PMA record

Approval order statement

Approval for the Cerene® Cryotherapy Device. This device is indicated for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.