BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S005 · Decision May 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
    PMA Number
    P930038
    Supplement Number
    S005
    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
    May 1, 1997
    Date Received
    April 16, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE INDICATIONS FOR USE FOR THE ANGIO-SEAL(TM) DEVICE. THE ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE IS NOW INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR INTERVENTIONAL PROCEDURES USING AN RETROGRADE APPROACH AND AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.

    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