PMA P100047S239

Device: HeartWare® Ventricular Assist System
Applicant: Medtronic
PMA number: P100047
Supplement: S239
Product code: DSQ
Decision date: 2026-07-28
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for the following design and manufacturing changes related to the HeartWare Ventricular Assist System’s Battery Charger AC Adapter: i) Component changes on the AC Adapter printed circuit board assembly (PCBA), ii) Addition of a ferrite component to the AC Adapter cable, and iii) Implementation of a new rework process for replacing the power supply of the AC Adapter.

Current openFDA PMA Record#

Device: HeartWare® Ventricular Assist System
Applicant: Medtronic
PMA number: P100047
Supplement: S239
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-07-28
Decision code: APPR
Date received: 2026-05-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the following design and manufacturing changes related to the HeartWare Ventricular Assist System’s Battery Charger AC Adapter: i) Component changes on the AC Adapter printed circuit board assembly (PCBA), ii) Addition of a ferrite component to the AC Adapter cable, and iii) Implementation of a new rework process for replacing the power supply of the AC Adapter.