PMA de la FDA

Artificial heart

Número de PMA: P030011 · 2026-07-09

SolicitanteSyncardia Systems, LLC

Fecha de decisión2026-07-09

Número PMAP030011

Código de productoLOZ

Clase del dispositivoClase 3

Especialidad médicaU

Comité asesorCV

Resumen del dispositivo

Artificial heart is the device name listed in this FDA 510(k) record. The listed applicant is Syncardia Systems, LLC. It received FDA 510(k) clearance on 2026-07-09. The device is classified under product code LOZ. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Artificial heart?

Artificial heart is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Syncardia Systems, LLC.

When did Artificial heart receive FDA 510(k) clearance?

The clearance date for Artificial heart can be found in the official FDA records.

Who is the listed applicant for Artificial heart?

The FDA 510(k) record lists Syncardia Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artificial heart?

The FDA product code for Artificial heart is LOZ.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.