PMA P160054S115
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S115
- Product code
- DSQ
- Decision date
- 2026-02-18
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- approval for an alternate board-to-cable connector for the HeartMate Power Module Printed Circuit Board Assembly
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S115
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-02-18
- Decision code
- APPR
- Date received
- 2025-11-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an alternate board-to-cable connector for the HeartMate Power Module Printed Circuit Board Assembly