BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P050043 · Supplement: S004 · Decision Mar 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)
    PMA Number
    P050043
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 2011
    Date Received
    January 18, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) REPLACING THE SEWN TWO-PIECE SMALL INTESTINE SUBMOCOSA (SIS) ASSEMBLY WITH A SINGLE SIS PIECE; 2) DECREASING THE SIS CUFF LENGTH AND RIBBON WIDTH; 3) MODIFYING THE SIS PATCH TO RELEASE WIRE CONNECTION; AND 4) CHANGING THE SHEATH MATERIAL FROM A HIGH DENSITY POLYETHYLENE (HDPE) TO FLUORINATED ETHYLENE PROPYLENE (FEP).

    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