- Device
- Freezor Xtra Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S099
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-08-22
- Decision code
- APPR
- Date received
- 2021-07-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software change to the CryoConsole system, primarily to enable the CryoMapping Mode for the Freezor Xtra Cardiac Cryoablation Catheter.