BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S052 · Decision Sep 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIO-SEAL VASCULAR CLOSURE DEVICE
    PMA Number
    P930038
    Supplement Number
    S052
    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
    September 26, 2008
    Date Received
    December 28, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE IN CLOSURE OF FEMORAL VENOUS PUNCTURE SITES AND FOR THE REMOVAL OF THE PRECAUTION STATEMENT RELATING TO THE USE OF THE ANTICOAGULANT WARFARIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL AND FEMORAL VENOUS PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING 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