BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S019 · Decision Mar 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
    PMA Number
    P930038
    Supplement Number
    S019
    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 8, 2000
    Date Received
    June 28, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the 6F Angio-Seal(TM) Hemostatic Puncture Closure Device. The device, as modified, will be marketed under the trade name 6F Angio-Seal(TM) Hemostatic Puncture Closure Device and is indicated for closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a 6 French or smaller procedureal sheath. The Angio-Seal (TM) device reduces the times to hemostasis, ambulation and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).

    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