PMA P180032S018
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S018
- Product code
- MNB
- Decision date
- 2024-07-17
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- approval for a modification to the manufacturing procedure for the Cerene Cryotherapy Device for the addition of a protective tape covering
Current openFDA PMA Record#
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S018
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2024-07-17
- Decision code
- OK30
- Date received
- 2024-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a modification to the manufacturing procedure for the Cerene Cryotherapy Device for the addition of a protective tape covering