- Device
- Arctic Front Advance Pro Cryoballoon Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S100
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-01-17
- Decision code
- OK30
- Date received
- 2019-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the supplier process for sanding the distal inside neck of the inner balloon used in the catheter.