BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P020047 · Supplement: S007 · Decision Feb 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM
    PMA Number
    P020047
    Supplement Number
    S007
    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
    February 9, 2007
    Date Received
    December 11, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR MODIFICATIONS TO THE W-CREST PORTION OF BOTH MULTI-LINK VISION STENT SYSTEMS AS WELL AS A NON-LINEAR LINK SHIFT TO THE MEDIUM DESIGN MULTI-LINK VISION CORONARY STENT SYSTEM.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary