PMA P240028S002
- Device
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S002
- Product code
- SEG
- Decision date
- 2025-09-03
- Classification
- Cardiovascular
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Approval order statement
- additional wire bonder equipment
Current openFDA PMA Record#
- Device
- WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S002
- Product code
- SEG
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Decision date
- 2025-09-03
- Decision code
- OK30
- Date received
- 2025-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- additional wire bonder equipment