PMA P060040S123

Device: HeartMate II Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S123
Product code: DSQ
Decision date: 2026-05-29
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for a change of material of the contacts on the PCBA and Ribbon Cable Connector interface of the 11 Volt Backup Battery of the HeartMate II (HMII) and HeartMate 3 (HM3) System Controllers

Current openFDA PMA Record#

Device: HeartMate II Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S123
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-05-29
Decision code: APPR
Date received: 2026-02-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change of material of the contacts on the PCBA and Ribbon Cable Connector interface of the 11 Volt Backup Battery of the HeartMate II (HMII) and HeartMate 3 (HM3) System Controllers