PMA supplement
P240028 S004: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
FDA PMA supplement · 30-Day Notice · EBR Systems, Inc.
Key facts
| Original PMA | P240028 |
|---|---|
| Supplement number | S004 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System |
| Generic name | Leadless Cardiac Resynchronization Therapy (CRT) |
| Applicant | EBR Systems, Inc. |
| Product code | SEG |
| Received date | Nov 17, 2025 |
| Decision date | Dec 15, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: