BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous (Valvuloplasty)

    PMA: P910054 · Supplement: S002 · Decision Feb 13, 2002
    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
    S002
    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
    February 13, 2002
    Date Received
    May 21, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INOUE BALLOON CATHETER WHICH IS INDICATED FOR PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY IN PATIENTS WITH HEMODYNAMICALLY SIGNIFICANT MITRAL VALVULAR STENOSIS RESULTING PRIMARILY FROM COMMISSURAL FUSION OF THE MITRAL VALVE CUSPS.

    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)