EXCOR Pediatric Ventricular Assist Device
FDA premarket approval P160035/S051 · decided 2025-07-18
Approval details
- PMA number
- P160035
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXCOR Pediatric Ventricular Assist Device
- Generic name
- Ventricular (assist) bypass
- Applicant
- Berlin Heart, Inc.
- Date received
- 2025-05-21
- Decision date
- 2025-07-18
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- The Woodlands, TX
- Statement
- Approval for changes to the mains power failure trigger board, toggle switch, and red flashing alarm LED of the IKUS driving unit
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