BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P020047 · Supplement: S065 · Decision Dec 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    Multi-Link 8 Coronary Stent System
    PMA Number
    P020047
    Supplement Number
    S065
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 15, 2017
    Date Received
    June 5, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Sterigenics UK Limited, Cotes Park Estate, Somercotes, Derbeyshire DE55 4NJ, United Kingdom, for sterilization of Multi-Link 8 / Multi-Link 8LL / Multi-Link 8SV Coronary Stent System manufactured at Abbott Vascular’s Clonmel, Ireland facility.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAF Stent, Coronary