PMA P180032S016
- Device
- Cerene Cryotherapy Device (Model Number FGS-7000)
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S016
- Product code
- MNB
- Decision date
- 2024-04-11
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- approval for labeling changes to address an error code that may occur during device use.
Current openFDA PMA Record#
- Device
- Cerene Cryotherapy Device (Model Number FGS-7000)
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S016
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2024-04-11
- Decision code
- APPR
- Date received
- 2024-03-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for labeling changes to address an error code that may occur during device use.