Xience Prime Everolimus Eluting Coronary Stent System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Xience Skypoint Everolimus Eluting Coronary Stent System FDA PMA
- Generic Name
- Coronary drug-eluting stent FDA PMA
Identifiers
- PMA Number
- P110019 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 Xience Prime Everolimus 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 de novo native coronary artery lesions up to 32 mm in length with reference vessel diameters between 2.25 mm and 4.25 mm.
This device is supplied sterile and intended for single-use under the direction of a healthcare professional. It is approved for use in the United States under an FDA Premarket Approval (PMA) and falls under device class III classification. The system includes a stent with an everolimus-eluting polymer coating and a delivery catheter, requiring appropriate storage and handling as specified in the accompanying instructions.
Frequently asked questions
What is the primary purpose of the Xience Prime Everolimus Eluting Coronary Stent System, and what types of patients is it designed for?
The Xience Prime Everolimus Eluting Coronary Stent System is designed to improve coronary luminal diameter in patients with symptomatic heart disease caused by de novo (new) native coronary artery lesions. It is specifically intended for lesions up to 32 millimeters in length with reference vessel diameters between 2.25 millimeters and 4.25 millimeters, ensuring it is tailored for patients requiring targeted treatment of these specific coronary artery conditions.
Is the Xience Prime Everolimus Eluting Coronary Stent System intended for reuse, or is it meant to be used only once?
The Xience Prime Everolimus Eluting Coronary Stent System is explicitly intended for single-use under the direction of a healthcare professional. This means it should not be reused after a single procedure, as its design and sterility are optimized for one-time deployment.
What sizes of coronary arteries does the Xience Prime Everolimus Eluting Coronary Stent System accommodate, and how is it supplied?
The system accommodates reference vessel diameters ranging from 2.25 millimeters to 4.25 millimeters. It is supplied sterile, including both the everolimus-eluting polymer-coated stent and a delivery catheter, ensuring readiness for immediate use in a clinical setting while maintaining sterility until deployment.
How should the Xience Prime Everolimus Eluting Coronary Stent System be stored, and what special handling instructions should be followed?
The Xience Prime Everolimus Eluting Coronary Stent System requires careful storage and handling as outlined in the accompanying instructions. While the exact storage conditions are not detailed here, the system’s sterility and performance depend on adherence to these guidelines, which typically include protection from moisture, extreme temperatures, and physical damage to preserve its integrity until use.
What regulatory pathway was followed for the approval of the Xience Prime Everolimus Eluting Coronary Stent System in the United States?
The Xience Prime Everolimus Eluting Coronary Stent System was approved in the United States through the FDA’s Premarket Approval (PMA) process, which is a rigorous review pathway for Class III devices. This approval confirms that the device meets the necessary safety and effectiveness standards for its intended use in improving coronary luminal diameter in the specified patient population.
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. Sources consulted: Everolimus-Eluting Stent Design, with Fluoropolymer | Abbott, XIENCE Market Leading Everolimus | Abbott, PDF Xience Prime Everolimus-Eluting Coronary Stent System, PDF EL2140413-01 Rev. A - Abbott - XIENCE Everolimus Eluting Coronary Stent ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110019 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA PMA P110019 24 fields · synced Sep 18, 2026