PMA P020045S078
- Device
- Freezor CryoAblation System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S078
- Product code
- LPB
- Decision date
- 2017-01-17
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for replacement of the operating system within the CryoConsole from Windows XP Embedded (WinXPE) to the Windows Embedded Standard 2009 (WES2009).
Current openFDA PMA Record#
- Device
- Freezor CryoAblation System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S078
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-01-17
- Decision code
- APPR
- Date received
- 2016-11-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for replacement of the operating system within the CryoConsole from Windows XP Embedded (WinXPE) to the Windows Embedded Standard 2009 (WES2009).