Resolute Integrity Zotarolimus-Eluting Coronary Stent System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM FDA PMA
- Generic Name
- Coronary drug-eluting stent FDA PMA
Identifiers
- PMA Number
- P110013 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 Integrity Zotarolimus-Eluting Coronary Stent System is a coronary drug-eluting stent designed to improve coronary luminal diameters in patients with symptomatic ischemic heart disease. It is intended for use in de novo lesions up to 27 mm in length within native coronary arteries, with reference vessel diameters ranging from 2.25 mm to 4.2 mm, including those with diabetes mellitus.
This device is supplied as a single-use system and is regulated under FDA Premarket Approval (PMA). It is intended for use in controlled clinical settings, such as cardiac catheterization labs, and requires proper handling and storage as per manufacturer guidelines. The system is not MRI-safe and must be used in accordance with its approved indications and limitations.
Frequently asked questions
What is the purpose of the Resolute Integrity Zotarolimus-Eluting Coronary Stent System?
The device is designed to improve coronary luminal diameters in patients with symptomatic ischemic heart disease, specifically for de novo lesions up to 27 mm in length within native coronary arteries with reference vessel diameters from 2.25 mm to 4.2 mm, including those with diabetes mellitus.
Is the Resolute Integrity Zotarolimus-Eluting Coronary Stent System reusable?
No, the device is supplied as a single-use system and should not be reused. It requires proper handling and storage according to manufacturer guidelines.
What are the approved indications for this coronary stent system?
The device is indicated for improving coronary luminal diameters in patients with symptomatic ischemic heart disease due to de novo lesions of length 27 mm or less in native coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm.
Is the Resolute Integrity Zotarolimus-Eluting Coronary Stent System MRI-safe?
No, the device is not MRI-safe and must be used in accordance with its approved indications and limitations.
What regulatory approval does the Resolute Integrity Zotarolimus-Eluting Coronary Stent System have?
The device is regulated under FDA Premarket Approval (PMA) with the PMA number P110013, as indicated in the authorizations field.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110013 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA PMA P110013 24 fields · synced Oct 6, 2026