- Device
- POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console
- Applicant
- Boston Scientific Corporation
- PMA number
- P220032
- Supplement
- S012
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-05-29
- Decision code
- APPR
- Date received
- 2026-05-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to amend the PAS protocol to terminate enrollment, discontinue all protocol-required follow-up beyond the 3-month visit, and conduct an analysis of all available data collected to date