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SynCardia Temporary Total Artificial Heart (TAH-T) System

FDA PMA

Class III (US FDA PMA)

PMA P030011

by SynCardia Systems, LLC

Identity

Trade Name
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) FDA PMA
Generic Name
Artificial heart FDA PMA

Identifiers

PMA Number
P030011 FDA PMA
FDA Product Code
LOZ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The SynCardia Temporary Total Artificial Heart (TAH-T) System is a total artificial heart indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular ventricular failure. It is intended for use inside the hospital.

The device is supplied as a sterile, single-use system for implant in a hospital setting. It has received FDA PMA approval (P030011) and is classified as a Class III device under product code LOZ.

Frequently asked questions

What is the SynCardia TAH-T System intended for?

The SynCardia TAH-T System is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular ventricular failure, and is intended for use inside the hospital.

Is the SynCardia TAH-T System reusable or single-use?

The SynCardia TAH-T System is supplied as a sterile, single-use device for implant, meaning it is intended for one-time use only and not designed for reprocessing or reuse.

What regulatory authorization does the SynCardia TAH-T System have?

The SynCardia TAH-T System has received FDA Premarket Approval (PMA) under application number P030011, with approval granted on October 15, 2004.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
SynCardia Systems, LLC

Sources (1)

  • FDA PMA P030011 24 fields · synced Oct 6, 2026