HeartMate 3 Left Ventricular Assist System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- HeartMate 3 Left Ventricular Assist System FDA PMA
- Generic Name
- Ventricular (assist) bypass FDA PMA
Identifiers
- PMA Number
- P160054 FDA PMA
- FDA Product Code
- DSQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The HeartMate 3 Left Ventricular Assist System is a continuous-flow, left ventricular assist device classified as a ventricular (assist) bypass under the OpenFDA nomenclature. It is designed to provide mechanical circulatory support by assisting the left ventricle in pumping blood to the body, intended for patients with advanced refractory left ventricular heart failure requiring short-term hemodynamic support, such as bridge to transplant or bridge to myocardial recovery.
This device is supplied as a sterile, implantable system and is intended for single-use in its intended applications. It is regulated under FDA Premarket Approval (PMA) with the approval number P160054. The system includes various model-specific components, each with unique registration numbers, and is intended for use in clinical settings where advanced cardiovascular support is required. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the HeartMate 3 Left Ventricular Assist System primarily used for in clinical practice?
The HeartMate 3 is designed to provide short-term mechanical circulatory support for patients with advanced, refractory left ventricular heart failure. It assists the left ventricle in pumping blood to the body, serving as a bridge to either heart transplant or myocardial recovery when patients require temporary hemodynamic stabilization.
Is the HeartMate 3 system intended for single-use or can it be reused after implantation?
The HeartMate 3 is explicitly intended for single-use in its intended applications. It is supplied as a sterile, implantable system, and reuse is not supported by the manufacturer’s design or regulatory approval.
How many unique model-specific components are included in the HeartMate 3 system, and how are they identified?
The HeartMate 3 system includes multiple model-specific components, each with distinct registration numbers. These components are identified by a series of unique FEI numbers (e.g., 3005228872, 3001236763) and registration numbers (e.g., 1721676, 3008454189), ensuring traceability and compliance with regulatory requirements.
What regulatory pathway does the HeartMate 3 follow, and what approval number is associated with it?
The HeartMate 3 follows the FDA Premarket Approval (PMA) pathway, which is required for high-risk devices like ventricular assist systems. It holds the approval number **P160054**, granted under the **FDA_PMA** authorization for its intended use in providing short-term hemodynamic support.
Are there specific storage or handling guidelines to maintain the device’s sterility and functionality?
Yes, the HeartMate 3 must be stored and handled according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, adherence to these protocols is critical to ensure the device remains uncontaminated and operational for its intended clinical application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HeartMate 3 LVAD | Abbott, HeartMate 3 LVAD System Information | Abbott, ABBOTT HEARTMATE 3 PATIENT MANUAL Pdf Download | ManualsLib, HeartMate 3™ Left Ventricular Assist System - Manuals+
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160054 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P160054 24 fields · synced Sep 18, 2026