PMA P180032S007
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S007
- Product code
- MNB
- Decision date
- 2021-07-22
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Change to the manufacturing procedure involving a tool design change and qualification of a new part supplier.
Current openFDA PMA Record#
- Device
- Cerene Cryotherapy Device
- Applicant
- Channel Medsystems, Inc.
- PMA number
- P180032
- Supplement
- S007
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-07-22
- Decision code
- OK30
- Date received
- 2021-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the manufacturing procedure involving a tool design change and qualification of a new part supplier.