PMA P060040S124

Device: HeartMate II Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S124
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 II Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S124
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.