- Device
- Freezor, Freezor Xtra and Freezor MAX Cardiac Cryoablation Catheter, Electrical Umbilical and Coax Umbilical cable
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S097
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-09-10
- Decision code
- APPR
- Date received
- 2021-07-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional sterilization site (Sterigenics Queensbury) and a new sterilization cycle (Cycle 410).