PMA P240028S004
- Device
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S004
- Product code
- SEG
- Decision date
- 2025-12-15
- Classification
- Cardiovascular
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Approval order statement
- to update manufacturing lot release testing requirements for M1000 and M2000 catheters.
Current openFDA PMA Record#
- Device
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S004
- Product code
- SEG
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Decision date
- 2025-12-15
- Decision code
- OK30
- Date received
- 2025-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update manufacturing lot release testing requirements for M1000 and M2000 catheters.