BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous (Valvuloplasty)

    PMA: P910054 · Supplement: S004 · Decision Jul 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Catheter, Percutaneous (Valvuloplasty)
    Trade Name
    TORAY INOUE BALLON CATHETER
    PMA Number
    P910054
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MAD
    Generic Name
    CATHETER, PERCUTANEOUS (VALVULOPLASTY)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 3, 2007
    Date Received
    November 15, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE GUIDEWIRE AND STYLET BULK MATERIAL.

    Classifications

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

    Product Code Device Name
    MAD Catheter, Percutaneous (Valvuloplasty)