PMA P020045S110
- Device
- Nitron CryoConsole, Nitron Foot Switch
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S110
- Product code
- LPB
- Decision date
- 2024-11-25
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- approval for a Nitron CryoConsole software upgrade from version 1.0 to version 1.1 and a new optional accessory called the Nitron Foot Switch
Current openFDA PMA Record#
- Device
- Nitron CryoConsole, Nitron Foot Switch
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S110
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2024-11-25
- Decision code
- APPR
- Date received
- 2024-08-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a Nitron CryoConsole software upgrade from version 1.0 to version 1.1 and a new optional accessory called the Nitron Foot Switch