FDA PMA

Coronary drug-eluting stent

PMA Number: P160043 · 2026-08-14

ApplicantMedtronic Vascular

Decision Date2026-08-14

PMA NumberP160043

Product CodeNIQ

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.