WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
FDA premarket approval P240028/S001 · decided 2025-06-18
Approval details
- PMA number
- P240028
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Applicant
- EBR Systems, Inc.
- Date received
- 2025-05-19
- Decision date
- 2025-06-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- SEG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- approval of the The WiSE-UP Registry (The WiSE System Utilization & Performance Registry) post-approval study protocol
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