HeartMate II Left Ventricular Assist System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM FDA PMA
- Generic Name
- Ventricular (assist) bypass FDA PMA
Identifiers
- PMA Number
- P060040 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 II Left Ventricular Assist System is a ventricular (assist) bypass device designed to provide mechanical circulatory support. It is classified as a Class III medical device and functions as an axial-flow, rotary ventricular assist device to augment or replace left ventricular function in patients with advanced heart failure.
This device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is supplied as a reusable system and may be used in hospital settings, outpatient care, or for patient transportation via ground, fixed-wing aircraft, or helicopter. The system requires surgical implantation, with one end attached to the left ventricle and the other connected to the ascending aorta. Authorized under FDA PMA (P060040), it adheres to regulatory standards for durable mechanical circulatory support.
Frequently asked questions
What is the primary clinical purpose of the HeartMate II Left Ventricular Assist System, and who is it intended for?
The HeartMate II is designed as a bridge-to-transplantation device for cardiac transplant candidates facing imminent death due to non-reversible left ventricular failure. It provides mechanical circulatory support to augment or replace left ventricular function in patients with advanced heart failure who are awaiting a heart transplant.
Is the HeartMate II system reusable, and where can it be used?
Yes, the HeartMate II is supplied as a reusable system. It is authorized for use in hospital settings, outpatient care, and for patient transportation via ground ambulances, fixed-wing aircraft, or helicopters, ensuring flexibility for different care environments.
How is the HeartMate II implanted, and what are the key components involved?
The HeartMate II requires surgical implantation, with one end attached to the left ventricle and the other connected to the ascending aorta. This design allows it to function as an axial-flow, rotary ventricular assist device to support or replace left ventricular function.
What regulatory approval does the HeartMate II hold, and what does this mean for its use?
The HeartMate II holds FDA PMA approval (P060040), which means it has undergone rigorous review and is authorized for its specified clinical use as a bridge-to-transplantation device. This approval ensures it meets regulatory standards for durable mechanical circulatory support.
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: Left Ventricular Assist Devices (LVADs) | Abbott, About the HeartMate II LVAD | Abbott, PDF HeartMate II® - manuals.eifu.abbott, Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P060040 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P060040 24 fields · synced Sep 18, 2026