# P240028: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

- Pathway: PMA
- Applicant: EBR Systems, Inc.
- Decided: Apr 11, 2025 after 225 days
- Product code: SEG (Leadless Cardiac Resynchronization Therapy (Crt))
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P240028
Methodology: https://510kreport.com/methodology