BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stent, Coronary

    PMA: P030009 · Supplement: S004 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    DRIVER CORONARY STENT SYSTEM FAMILY OF PRODUCTS
    PMA Number
    P030009
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 22, 2005
    Date Received
    November 30, 2005
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN AN APPROVED SUPPLIER'S PROCESSING STEPS TO ALLOW THEM TO FURTHER PROCESS A SUBASSEMBLY IN ACCORDANCE WITH YOUR OWN MANUFACTURING OPERATIONS AND DEVICE SPECIFICATIONS.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary