- Device
- Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S118
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-12-16
- Decision code
- APPR
- Date received
- 2021-07-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.