FDA PMA

VALVULA-CORACIANA, MECANICA

Número do PMA: P810002 · 2026-06-11

RequerenteABBOTT MEDICAL

Data da decisão2026-06-11

Número PMAP810002

Código do produtoLWQ

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

HEART-VALVE, MECHANICAL is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-06-11. The device is classified under product code LWQ. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the HEART-VALVE, MECHANICAL?

HEART-VALVE, MECHANICAL is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is ABBOTT MEDICAL.

When did HEART-VALVE, MECHANICAL receive FDA 510(k) clearance?

The clearance date for HEART-VALVE, MECHANICAL can be found in the official FDA records.

Who is the listed applicant for HEART-VALVE, MECHANICAL?

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 HEART-VALVE, MECHANICAL?

The FDA product code for HEART-VALVE, MECHANICAL is LWQ.

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Fonte oficial

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