PMA P180032S015
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S015
- Product code
- MNB
- Decision date
- 2023-11-16
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for labeling changes that add and/or strengthen instructions that are intended to enhance the safe use of the device.
Current openFDA PMA Record#
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S015
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2023-11-16
- Decision code
- APPR
- Date received
- 2023-10-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes that add and/or strengthen instructions that are intended to enhance the safe use of the device.