- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S005
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-04-27
- Decision code
- APPR
- Date received
- 2021-03-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of additional adverse event information and clarification of troubleshooting instructions to the labeling of the instructions for use (IFU-3243 Rev E).