BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S080 · Decision Apr 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM
    PMA Number
    P960043
    Supplement Number
    S080
    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
    April 15, 2013
    Date Received
    July 20, 2012
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    13M-0464

    Advisory Committee Statement

    APPROVAL FOR THE PERCLOSE® PROGLIDE¿ SUTURE MEDIATED CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTSWHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21 F SHEATHS; FOR SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE AREREQUIRED.

    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