- Device
- Artic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S129
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-08-24
- Decision code
- OK30
- Date received
- 2022-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing and supplier changes to the female coaxial connector and female coaxial fitting of the Arctic Front Advance (AFA), Arctic Front Advance Pro (AFA Pro), Freezor, Freezor Xtra, and Freezor MAX cryoablation catheters.