FDA PMA

Stent, superficial femoral artery, drug-eluting

Numéro PMA : P180011 · 2026-08-21

DemandeurBoston Scientific Corp

Date de décision2026-08-21

Numéro PMAP180011

Code produitNIU

Classe de dispositifClasse 3

Spécialité médicaleU

Comité consultatifCV

Résumé du dispositif

Stent, superficial femoral artery, drug-eluting is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-08-21. The device is classified under product code NIU. It was reviewed by the CV advisory panel.

Questions fréquentes

What is the Stent, superficial femoral artery, drug-eluting?

Stent, superficial femoral artery, drug-eluting is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Boston Scientific Corp.

When did Stent, superficial femoral artery, drug-eluting receive FDA 510(k) clearance?

The clearance date for Stent, superficial femoral artery, drug-eluting can be found in the official FDA records.

Who is the listed applicant for Stent, superficial femoral artery, drug-eluting?

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

What is the FDA product code for Stent, superficial femoral artery, drug-eluting?

The FDA product code for Stent, superficial femoral artery, drug-eluting is NIU.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Source officielle

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