PMA P100047S234

Device: HeartWare® HVAD System
Applicant: Medtronic
PMA number: P100047
Supplement: S234
Product code: DSQ
Decision date: 2026-02-18
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: approval for design, manufacturing, and labeling changes to: (1) update the HVAD Controller design output specifications; (2) update manufacturing procedures to support the revised specifications; and (3) update labels and literature to reflect the new Ingress Protection (IP) Rating for the HVAD Controller.

Current openFDA PMA Record#

Device: HeartWare® HVAD System
Applicant: Medtronic
PMA number: P100047
Supplement: S234
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-02-18
Decision code: APPR
Date received: 2025-11-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for design, manufacturing, and labeling changes to: (1) update the HVAD Controller design output specifications; (2) update manufacturing procedures to support the revised specifications; and (3) update labels and literature to reflect the new Ingress Protection (IP) Rating for the HVAD Controller.