XIENCE Xpedition Everolimus Eluting Coronary Stent System 3.50 mm x 18 mm / Rapid-Exchange


Product Overview

XIENCE Xpedition Everolimus Eluting Coronary Stent System 3.50 mm x 18 mm / Rapid
XIENCE XPEDITION - 1074350-18


Device Description

A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00
  • Special Storage Condition, Specify
    • Store in a dry, dark, cool place. Protect from light. Store at 25 degrees C; excursions between 15 to 30 degrees C permitted.
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 25.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NIQ

    Device Name: Coronary Drug-Eluting Stent

    Device Class: 3

    Physical State: N/A

    Definition: Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 08717648162541

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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