PMA P180032S014
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S014
- Product code
- MNB
- Decision date
- 2023-11-14
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for software changes for the air pump.
Current openFDA PMA Record#
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S014
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2023-11-14
- Decision code
- APPR
- Date received
- 2023-09-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes for the air pump.