BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P920004 · Supplement: S006 · Decision Apr 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASOSEAL (TM)
    PMA Number
    P920004
    Supplement Number
    S006
    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, 1997
    Date Received
    February 25, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE INDICATIONS FOR USE TO INCLUDE SUE OF VASOSEAL(R) FOLLOWING STENT IMPLANTATION. THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE IS NOW INDICATED FOR USE IN REDUCING TIEM TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY, BALLOON ANGIOPLASTY OR STENT PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL(R) VHD IS ALSO INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS IN BALLOON ANGIOPLASTY AND STENT PATIENTS WHEN IMMEDIATE SHEALTH REMOVAL IS DESIRED. HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.

    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