PMA P020045S113
- Device
- Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S113
- Product code
- LPB
- Decision date
- 2026-04-23
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- approval for Freezor Coaxial Connector Adhesive Modifications
Current openFDA PMA Record#
- Device
- Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S113
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2026-04-23
- Decision code
- APPR
- Date received
- 2026-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for Freezor Coaxial Connector Adhesive Modifications