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PMA de la FDA

Transcatheter septal occluder

Número de PMA: P000039 · 2026-05-28

SolicitanteABBOTT MEDICAL
Fecha de decisión2026-05-28
Número PMAP000039
Código de productoMLV
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Transcatheter septal occluder is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-05-28. The device is classified under product code MLV. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Transcatheter septal occluder?

Transcatheter septal occluder is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is ABBOTT MEDICAL.

When did Transcatheter septal occluder receive FDA 510(k) clearance?

The clearance date for Transcatheter septal occluder can be found in the official FDA records.

Who is the listed applicant for Transcatheter septal occluder?

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

What is the FDA product code for Transcatheter septal occluder?

The FDA product code for Transcatheter septal occluder is MLV.

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Fuente oficial

Ver en la base de datos de la FDA →

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