BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P900043 · Supplement: S039 · Decision May 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM(RX)/BX VELOCITY STENT WITHHEPACOAT ON RAPTORRAIL STENT DELIVERY
    PMA Number
    P900043
    Supplement Number
    S039
    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 3, 2002
    Date Received
    April 5, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR FOUR CHANGES TO THE QUALITY PLAN FOR THE DEVICE.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary