PMA P180032S003
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S003
- Product code
- MNB
- Decision date
- 2021-02-25
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for the addition of information from the post-approval study to the patient labeling and instructions for use
Current openFDA PMA Record#
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S003
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-02-25
- Decision code
- APPR
- Date received
- 2020-10-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the addition of information from the post-approval study to the patient labeling and instructions for use