- Device
- Artic Front Advance Pro Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S106
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-06-25
- Decision code
- OK30
- Date received
- 2020-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor manufacturing changes to the Artic Front Advance Pro Cryoablation catheters to improve manufacturing efficiency of the balloon assembly.