PMA P180032S002
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S002
- Product code
- MNB
- Decision date
- 2020-11-18
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval of labeling changes to improve safety information related to EMC and electrical safety.
Current openFDA PMA Record#
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S002
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2020-11-18
- Decision code
- APPR
- Date received
- 2020-10-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of labeling changes to improve safety information related to EMC and electrical safety.