BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P010049 · Supplement: S012 · Decision Aug 31, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    SURESTAT ARTERIAL CLOSURE SYSTEM
    PMA Number
    P010049
    Supplement Number
    S012
    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 31, 2004
    Date Received
    July 19, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A POLYSACCHARIDE (CHITOSAN) TO THE HEMOSTATIC PLEDGET FORMULATION AND REQUESTED TO RENAME THE DEVICE FROM THE QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM TO THE SURESTAT ARTERIAL CLOSURE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURESTAT ARTERIAL CLOSURE SYSTEM AND IS INDICATED FOR "DELIVERY OF T-FOAM FOR EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS. THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES."

    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