HeartMate 3 Left Ventricular Assist System
FDA premarket approval P160054 · Ventricular (assist) bypass
PMA numberP160054
Approval
- Applicant
- Abbott Medical
- Received
- December 5, 2016
- Decision date
- August 23, 2017 (APPR)
- Supplements
- 130, latest September 9, 2026
- Product code
- DSQ – Ventricular (Assist) Bypass
Approval order statement
Approval for the HeartMate 3 Left Ventricular Assist System. This device is indicated for providing short-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.