PMA P240028S003
- Device
- WiSE (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S003
- Product code
- SEG
- Decision date
- 2025-10-03
- Classification
- Cardiovascular
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Approval order statement
- approval for an additional energy calibration inspection for the Transmitter subassembly
Current openFDA PMA Record#
- Device
- WiSE (Wireless Stimulation of the Endocardium Technology) CRT System
- Applicant
- EBR Systems, Inc.
- PMA number
- P240028
- Supplement
- S003
- Product code
- SEG
- Generic name
- Leadless Cardiac Resynchronization Therapy (CRT)
- Decision date
- 2025-10-03
- Decision code
- APPR
- Date received
- 2025-09-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an additional energy calibration inspection for the Transmitter subassembly