BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970020 · Supplement: S043 · Decision Jul 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    ACS MULTI-LINK DUET CORONARY STENT SYSTEM
    PMA Number
    P970020
    Supplement Number
    S043
    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
    July 22, 2003
    Date Received
    February 19, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CHANGE THE POST-APPROVAL REQUIREMENT PERIOD FROM 5 TO 4 YEARS AND TO UPDATE THE LABELING WITH CLINICAL DATA FROM 4 YEAR FOLLOW-UP.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary