BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S002 · Decision Dec 29, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL
    PMA Number
    P960043
    Supplement Number
    S002
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 29, 1997
    Date Received
    June 2, 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 (PVS) Systems. The devices, as modified, will be marketed under the trade names Prostar(R) Plus 8 French, Prostar(R) Plus 10 French, and Prostar(R) XL 8 French PVS Systems. The Prostar(R) Plus and Prostar(R) XL PVS Systems consist of a PVS Device and a Perclose(R) Knot Pusher. The Prostar(R) Plus and Prostart(R) XL PVS Systems are indicated for the percutaneous deliveyr of sutures for closing the common femoral artery access site and reducing hte time to hemostasis and ambulation (patient walks ten feet) of patients who have undegone catheterization procedures using 6.5 French to 10 French sheaths.