- Device
- Arctic Front Cryocatheter System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S107
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-08-13
- Decision code
- APPR
- Date received
- 2020-06-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the buckling force requirement for Arctic Front Advance (AFA) (Models 2AF234 and 2AF284).