- Device
- Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S125
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-03-16
- Decision code
- OK30
- Date received
- 2022-02-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change, a cavity mold change, and clarified specifications for the Y-Block fitting.