WiSE (Wireless Stimulation of the Endocardium Technology) CRT System
FDA premarket approval P240028/S003 · decided 2025-10-03
Approval details
- PMA number
- P240028
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- 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
- 2025-09-10
- Decision date
- 2025-10-03
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- SEG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- approval for an additional energy calibration inspection for the Transmitter subassembly
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