PMA P160054S125

Device: HeartMate 3™ Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S125
Product code: DSQ
Decision date: 2026-06-10
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for alternate connector components for the connection interface between the user interface (UI) membrane and the main printed circuit board assembly (PCBA) of the HeartMate II (HMII) System Controller and HeartMate 3 (HM3) System Controller.

Current openFDA PMA Record#

Device: HeartMate 3™ Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S125
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-06-10
Decision code: APPR
Date received: 2026-03-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for alternate connector components for the connection interface between the user interface (UI) membrane and the main printed circuit board assembly (PCBA) of the HeartMate II (HMII) System Controller and HeartMate 3 (HM3) System Controller.