FDA PMA

Coronary drug-eluting stent

Número do PMA: P160043 · 2026-08-14

RequerenteMedtronic Vascular

Data da decisão2026-08-14

Número PMAP160043

Código do produtoNIQ

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

Coronary drug-eluting stent is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2026-08-14. The device is classified under product code NIQ. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Coronary drug-eluting stent?

Coronary drug-eluting stent is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Medtronic Vascular.

When did Coronary drug-eluting stent receive FDA 510(k) clearance?

The clearance date for Coronary drug-eluting stent can be found in the official FDA records.

Who is the listed applicant for Coronary drug-eluting stent?

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

What is the FDA product code for Coronary drug-eluting stent?

The FDA product code for Coronary drug-eluting stent is NIQ.

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Fonte oficial

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