BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S031 · Decision Aug 28, 2001
    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 STS PLATFORM
    PMA Number
    P930038
    Supplement Number
    S031
    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
    August 28, 2001
    Date Received
    March 20, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING THE LOCKING CAP FEATURE ONTO THE DELIVERY SYSTEM OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE WITH SELF-TIGHTENING SLIPKNOT (STS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND IS INDICATED FOR CLOSING AND REDUCING THE TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHIC PROCEDURES OR INTERVENTIONAL PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH FOR THE 8F ANGIO-SEAL DEVICE AND A 6 FRENCH OR SMALLER PROCEDURAL SHEATH FOR THE 6F ANGIO-SEAL DEVICE.

    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