PMA P180032
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S011
- Product code
- MNB
- Decision date
- 2026-09-15
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- a change in supplier of the uterine liner material
Current openFDA PMA Record#
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S024
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2026-09-15
- Decision code
- OK30
- Date received
- 2026-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in supplier of the uterine liner material