- Device
- Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S116
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-08-06
- Decision code
- APPR
- Date received
- 2021-07-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co., Villalba for full assembly, sterilization, packaging, and distribution.