PMA P160054S122
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S122
- Product code
- DSQ
- Decision date
- 2026-05-27
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for additional and replacement suppliers for MOSFETs used in the system controller
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S122
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-05-27
- Decision code
- APPR
- Date received
- 2026-02-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for additional and replacement suppliers for MOSFETs used in the system controller