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Xience V Everolimus Eluting Coronary Stent System

FDA PMA

Class III (US FDA PMA)

PMA P070015

by Abbott Vascular Inc.

Identity

Trade Name
XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS FDA PMA
Generic Name
Coronary drug-eluting stent FDA PMA

Identifiers

PMA Number
P070015 FDA PMA
FDA Product Code
NIQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The XIENCE V Everolimus-Eluting Coronary Stent System is a Coronary Drug-Eluting Stent designed to improve coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions. It is indicated for lesions up to 28 mm in length with reference vessel diameters ranging from 2.5 mm to 4.25 mm.

This device is supplied as a sterile, single-use system and is regulated under FDA_PMA (PMA Number: P070015). It is intended for use in percutaneous coronary interventions (PCI) and is distributed under the trade names XIENCE and PROMUS Everolimus-Eluting Coronary Stent Systems. No MRI safety information is specified in the provided data.

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 Drug-Eluting Stents | Abbott, PDF The XIENCE V® and XIENCE nano m Everolimus Eluting Coronary Stent System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Vascular Inc.
FDA Applicant
Abbott Vascular, Inc.

Sources (1)

  • FDA PMA P070015 24 fields · synced Sep 18, 2026