PMA P180032S011
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S011
- Product code
- MNB
- Decision date
- 2023-01-17
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for a modification to the manufacturing process to improve the PCB-to-battery tray solder joint for the Cerene Controller Board.
Current openFDA PMA Record#
- Device
- Cerene® Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S011
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2023-01-17
- Decision code
- APPR
- Date received
- 2022-12-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a modification to the manufacturing process to improve the PCB-to-battery tray solder joint for the Cerene Controller Board.