- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S009
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-09-01
- Decision code
- OK30
- Date received
- 2021-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the manufacturing procedure for the Cerene Cryotherapy Device – namely, an update to the manufacturing test software and manufacturing instructions.