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FDA PMA

Coronary drug-eluting stent

PMA Number: P210014 · 2023-04-06

ApplicantAdvanced Bifurcation Systems, Inc.
Decision Date2023-04-06
PMA NumberP210014
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 Advanced Bifurcation Systems, Inc.. It received FDA 510(k) clearance on 2023-04-06. 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 2023-04-06. The listed applicant is Advanced Bifurcation Systems, Inc..

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 Advanced Bifurcation Systems, Inc. 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

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

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