FDA PMA

System, hemodynamic, implantable

Número do PMA: P230040 · 2026-09-25

RequerenteEndotronix, Inc.

Data da decisão2026-09-25

Número PMAP230040

Código do produtoMOM

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

System, hemodynamic, implantable is the device name listed in this FDA 510(k) record. The listed applicant is Endotronix, Inc.. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code MOM. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the System, hemodynamic, implantable?

System, hemodynamic, implantable is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Endotronix, Inc..

When did System, hemodynamic, implantable receive FDA 510(k) clearance?

The clearance date for System, hemodynamic, implantable can be found in the official FDA records.

Who is the listed applicant for System, hemodynamic, implantable?

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

What is the FDA product code for System, hemodynamic, implantable?

The FDA product code for System, hemodynamic, implantable is MOM.

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Fonte oficial

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