PMA
P240028: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
FDA PMA · Leadless Cardiac Resynchronization Therapy (CRT) · EBR Systems, Inc.
Key facts
| PMA number | P240028 |
|---|---|
| Trade name | WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System |
| Generic name | Leadless Cardiac Resynchronization Therapy (CRT) |
| Applicant | EBR Systems, Inc. |
| Owner/operator | EBR Systems Inc. |
| Product code | SEG |
| Approval date | Apr 11, 2025 |
| Docket number | 25M-1081 |
| Notice date | Apr 14, 2025 |
| Establishment registration | 3013596742 |
| FEI number | 3013596742 |
At a glance
- 1–9 Supplements
- Mar 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: