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

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S037 · Decision Feb 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S037
    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
    February 13, 2002
    Date Received
    January 14, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    RECLASSIFICATION OF THE CLEANROOM FROM CLASS 10,000 OF THE FEDERAL STANDARD 209E TO CLASS 8 OF ISO 14644-1 USED IN THE MANUFACTURE OF THE PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS.

    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