PMA
P210027: QDOT MICRO™ System
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation · Biosense Webster, Inc.
Key facts
| PMA number | P210027 |
|---|---|
| Trade name | QDOT MICRO™ System |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Biosense Webster, Inc. |
| Owner/operator | BIOSENSE WEBSTER, INC. |
| Product code | OAE |
| Approval date | Nov 23, 2022 |
| Establishment registration | 3013300026 |
| FEI number | 3013300026 |
At a glance
- 10–99 Supplements
- Sep 15, 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- No Withdrawn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: