WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
FDA premarket approval P240028/S004 · decided 2025-12-15
Approval details
- PMA number
- P240028
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- 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.
- Date received
- 2025-11-17
- Decision date
- 2025-12-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- SEG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- to update manufacturing lot release testing requirements for M1000 and M2000 catheters.
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