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EBR Systems, Inc.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
WiSE CRT System	5100	FDA UDI	Class III	Active
WiSE CRT System	2000	FDA UDI	Class III	Active
WiSE CRT System	4100	FDA UDI	Class III	Active
WiSE CRT System	1000	FDA UDI	Class III	Active
WiSE CRT System	3100	FDA UDI	Class III	Active
WiSE (Wireless Stimulation of the Endocardium Technology) CRT System	P240028	FDA PMA	Class III	Active

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