BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S001 · Decision Nov 5, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
    PMA Number
    P960043
    Supplement Number
    S001
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 5, 1997
    Date Received
    May 1, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modified Percutaneous Vascular Surgical devices. The devices, as modified, will be marketed under the trade names Techstar(TM) 6 French Percutaneous Vascular Surgical (PVS) System and Techstar(TM) XL 6 French PVS System and are indicated for the percutaneous delivery of sutures for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 French sheaths.