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

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S079 · Decision May 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM
    PMA Number
    P960043
    Supplement Number
    S079
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 3, 2012
    Date Received
    April 4, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE SUPPLIER FOR THE COILED SUTURE TUBE.

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular