Identity
- Trade Name
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System FDA PMA
- Generic Name
- Leadless Cardiac Resynchronization Therapy (CRT) FDA PMA
Identifiers
- PMA Number
- P240028 FDA PMA
- FDA Product Code
- SEG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The WiSE CRT System is a leadless cardiac resynchronization therapy (CRT) device designed for adult patients aged 22 and older. It delivers wireless endocardial stimulation to synchronize heart contractions in patients with existing or eligible right ventricular pacing systems, addressing cases where coronary sinus (CS) lead implantation is unsuccessful or high-risk.
This system is intended for patients classified as 'previously untreatable' due to failed CS lead implantation or inoperable LV leads, as well as those deemed high-risk for standard CRT upgrades. Supplied as a sterile, implantable device, it requires surgical placement and is regulated under FDA PMA approval (P240028). The device is not indicated for prior CRT non-responders or leadless pacemaker co-implants using conductive communication.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P240028 | Class III | Active |
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Manufacturer
- Manufacturer
- EBR Systems, Inc.
Sources (1)
- FDA PMA P240028 24 fields · synced Sep 18, 2026