PMA P240028
- Device
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- Product code
- SEG
- Decision date
- 2026-03-27
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Approval order statement
- qualification of a new supplier for the IrOx coating process on the needle tip of the WiSE CRT System
Current openFDA PMA Record#
- Device
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S006
- Product code
- SEG
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of a new supplier for the IrOx coating process on the needle tip of the WiSE CRT System