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Resolute Onyx Zotarolimus-Eluting Coronary Stent System

FDA PMA

Class III (US FDA PMA)

PMA P160043

by Medtronic Vascular

Identity

Trade Name
RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM FDA PMA
Generic Name
Coronary drug-eluting stent FDA PMA

Identifiers

PMA Number
P160043 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 Resolute Onyx Zotarolimus-Eluting Coronary Stent System is a coronary drug-eluting stent indicated for improving coronary luminal diameters in patients with symptomatic ischemic heart disease due to de novo lesions. It is designed for use in native coronary arteries with reference vessel diameters ranging from 2.25 mm to 5.0 mm and lesion lengths up to 35 mm, including in patients with diabetes mellitus.

Supplied as a sterile, single-use device, the stent is delivered via catheter in a cardiac catheterization laboratory setting. It is not MRI conditional unless explicitly stated in labeling, and storage conditions follow manufacturer specifications. The device holds FDA PMA approval (P160043) and is manufactured by Medtronic Vascular in Santa Rosa, CA.

Frequently asked questions

What is the maximum lesion length this stent is approved to treat?

The Resolute Onyx Zotarolimus-Eluting Coronary Stent System is approved for de novo lesions with a length of less than or equal to 35 mm, as stated in the approval documentation.

What is the range of reference vessel diameters this stent can be used in?

The stent is indicated for use in native coronary arteries with reference vessel diameters ranging from 2.25 mm to 5.0 mm, according to the device's approval specifications.

Is this stent approved for use in patients with diabetes mellitus?

Yes, the device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, as specified in the approval statement.

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
Medtronic Vascular

Sources (1)

  • FDA PMA P160043 24 fields · synced Oct 6, 2026