PMA P180032S022
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S022
- Product code
- MNB
- Decision date
- 2025-12-18
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for introducing a coating to the controller printed circuit board.
Current openFDA PMA Record#
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S022
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2025-12-18
- Decision code
- APPR
- Date received
- 2025-12-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for introducing a coating to the controller printed circuit board.