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

    Catheter, Percutaneous (Valvuloplasty)

    PMA: P910054 · Supplement: S010 · Decision Jul 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Catheter, Percutaneous (Valvuloplasty)
    Trade Name
    INOUE BALLOON CATHETER
    PMA Number
    P910054
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MAD
    Generic Name
    CATHETER, PERCUTANEOUS (VALVULOPLASTY)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 1, 2024
    Date Received
    June 3, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in the production line (spinning mill) for the polyester yarn used in the mesh portion of the Inoue-Balloon Catheter

    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)