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EluNIR Ridaforolimus Eluting Coronary Stent System

FDA PMA

Class III (US FDA PMA)

PMA P170008

by Medinol Ltd.

Identity

Trade Name
EluNIR™ Ridaforolimus Eluting Coronary Stent System FDA PMA
Generic Name
Coronary drug-eluting stent FDA PMA

Identifiers

PMA Number
P170008 FDA PMA
FDA Product Code
NIQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The EluNIR Ridaforolimus Eluting Coronary Stent System is a Coronary Drug-Eluting Stent, designed to improve coronary luminal diameter in patients with symptomatic heart disease. It is intended for use in native coronary arteries with de novo lesions up to 30mm in length and reference diameters between 2.50mm and 4.25mm. The device delivers a ridaforolimus-eluting coating to reduce restenosis and promote vessel healing.

This stent system is supplied sterile and intended for single-use in interventional cardiology settings. It is classified as a Class III medical device under FDA regulations and has received FDA_PMA approval (PMA Number: P170008). The system is non-magnetic and MRI-safe for standard imaging protocols, though specific MRI conditions should be confirmed with the manufacturer. Storage requires protection from moisture and extreme temperatures, adhering to standard sterile packaging guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Medinol Ltd.
FDA Applicant
Medinol, Ltd.

Sources (1)

  • FDA PMA P170008 24 fields · synced Sep 18, 2026