FDA PMA

Artificial heart

Número do PMA: P030011 · 2026-07-09

RequerenteSyncardia Systems, LLC

Data da decisão2026-07-09

Número PMAP030011

Código do produtoLOZ

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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