- Device
- Arctic Front Advance and Arctic Front Advance Pro
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S113
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-03-03
- Decision code
- OK30
- Date received
- 2021-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the final inspection test methods for the Balloon Outer Diameter and Pushbutton Clearance.