WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
FDA premarket approval P240028 · decided 2025-04-11
Approval details
- 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.
- Date received
- 2024-08-29
- Decision date
- 2025-04-11
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- SEG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing or are eligible for an implanted right ventricular pacing system, and are in one of the following two categories: Patients in whom previous coronary sinus (CS) lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as "previously untreatable"; Patients with previously implanted pacemakers or
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