PMA P020045S096
- Device
- 7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S096
- Product code
- LPB
- Decision date
- 2021-06-01
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Replacement of a reflow oven used at a supplier.
Current openFDA PMA Record#
- Device
- 7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S096
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-06-01
- Decision code
- OK30
- Date received
- 2021-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of a reflow oven used at a supplier.