PMA
P220032: POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation · Boston Scientific Corporation
Key facts
| PMA number | P220032 |
|---|---|
| Trade name | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | OAE |
| Approval date | Aug 8, 2023 |
| Docket number | 23M-3943 |
| Notice date | Sep 15, 2023 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- May 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: