- Device
- POLARx™ Cryoablation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P220032
- Supplement
- S011
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2025-08-14
- Decision code
- APPR
- Date received
- 2025-07-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for a manufacturing site located at Boston Scientific de Costa Rica, S.R.L., El Coyol Alajuela, Coyol, Costa Rica (FEI: 3007695959) to perform ethylene oxide sterilization activities