PMA
P200002: EPi-Sense Guided Coagulation System
FDA PMA · Surgical cardiac ablation device, for treatment of atrial fibrillation · AtriCure, Inc.
Key facts
| PMA number | P200002 |
|---|---|
| Trade name | EPi-Sense Guided Coagulation System |
| Generic name | Surgical cardiac ablation device, for treatment of atrial fibrillation |
| Applicant | AtriCure, Inc. |
| Owner/operator | ATRICURE, INC. |
| Product code | OCM |
| Approval date | Apr 28, 2021 |
| Establishment registration | 3011706110 |
| FEI number | 3011706110 |
At a glance
- 10–99 Supplements
- Sep 24, 2026 Latest supplement decision
- No Withdrawn
- No 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: