- Device
- Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S117
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-09-10
- Decision code
- APPR
- Date received
- 2021-07-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional sterilization site.