- Device
- 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S094
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-03-17
- Decision code
- OK30
- Date received
- 2021-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional inspection criteria for components during manufacturing.