Identity
- Trade Name
- HEARTMATE VE LVAS FDA PMA
- Generic Name
- Ventricular (assist) bypass FDA PMA
Identifiers
- PMA Number
- P920014 FDA PMA
- FDA Product Code
- DSQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The HeartMate 1000A IP LVAD is a left ventricular assist device (LVAD) classified as a ventricular (assist) bypass system. It is designed to provide mechanical circulatory support by assisting or replacing the function of a failing left ventricle, helping to maintain adequate blood flow to the body.
This device is intended for use in the operating room and intensive care settings, supplied as a sterile, single-use system. It operates under FDA approval (PMA P920014) and is regulated under Product Code DSQ. The device is available in a single configuration as specified in the original approval, with no additional sizes or variants noted in the regulatory data.
Frequently asked questions
What clinical settings is the HeartMate 1000A IP LVAD designed for use in and why is this important for clinicians?
The HeartMate 1000A IP LVAD is specifically designed for use in the operating room and intensive care settings. This is important for clinicians because these environments provide the necessary monitoring, support, and infrastructure to manage a patient requiring continuous mechanical circulatory support, such as close hemodynamic monitoring, sterile conditions, and immediate access to advanced care if complications arise.
Is the HeartMate 1000A IP LVAD intended for single-use or can it be reused, and what does this mean for inventory management?
The HeartMate 1000A IP LVAD is supplied as a sterile, single-use system. This means each device is intended for one patient only, reducing the risk of cross-contamination and ensuring sterility. For inventory management, this implies hospitals must plan for higher stock levels or rely on timely restocking, as reuse is not permitted.
Are there multiple sizes or configurations available for the HeartMate 1000A IP LVAD, or is it offered in a single standardized model?
The HeartMate 1000A IP LVAD is available in a single configuration as specified in its original FDA approval. There are no additional sizes or variants noted in the regulatory data, meaning clinicians must rely on this one standardized model for all patients requiring this type of support.
What regulatory pathway was followed for approval of the HeartMate 1000A IP LVAD, and what does this indicate about its safety and efficacy?
The HeartMate 1000A IP LVAD was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P920014. This pathway is reserved for high-risk medical devices and requires rigorous clinical trials to demonstrate safety and effectiveness. The approval indicates that the device has met stringent regulatory standards for use in assisting or replacing the function of a failing left ventricle.
How does the regulatory classification of the HeartMate 1000A IP LVAD (Class III) impact its use in clinical practice?
The HeartMate 1000A IP LVAD is classified as a Class III device, which means it is considered high-risk and requires the highest level of regulatory oversight. This classification reflects its critical role in supporting life-sustaining functions, necessitating thorough pre-market evaluation to ensure safety and efficacy. Clinicians should be aware that its use is closely monitored and requires adherence to strict protocols, as outlined in the FDA approval.
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: TCI HEARTMATE 1000A IP LVAS (UDI: P920014) Specs & FDA Data, TCI HEARTMATE(R) 1000A IP LVAD PMA P920014S001 - FDA.report, TCI HEARTMATE (R) 1000A IP LVAD 510 (k) FDA Approval, Ventricle assist pump control unit - HeartMate II - Thoratec ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P920014 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thoratec Corp
Sources (1)
- FDA PMA P920014 24 fields · synced Sep 18, 2026