BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P980009 · Supplement: S011 · Decision Apr 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    SCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM
    PMA Number
    P980009
    Supplement Number
    S011
    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
    April 12, 2002
    Date Received
    March 8, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO A PROCESS STEP IN WHICH THE MAGIC WALLSTENT DEVICE TIP IS INSERT-MOLDED ONTO THE INNER CATHETER SHAFT RATHER THAN ADHESIVELY ATTACHED.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary