BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P900043 · Supplement: S016 · Decision May 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM
    PMA Number
    P900043
    Supplement Number
    S016
    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
    May 27, 1999
    Date Received
    May 19, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a label to the outside front panel of the MiniCrown carton that states the following: "Do not induce a vacuum on the delivery system prior to reaching the target lesion."

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary