BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous (Valvuloplasty)

    PMA: P910054 · Supplement: S009 · Decision May 24, 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
    S009
    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
    May 24, 2024
    Date Received
    October 31, 2023
    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 the use of packaging pouches with a change in the specification of a film component, the use of a new plasma welding machine for an accessory device, and the use of a new plating company for the plating of the hubs of device components.

    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)