BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S008 · Decision Jul 17, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S008
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 17, 1998
    Date Received
    June 22, 1998
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revised labeling and training materials including, the PVS Guidelines for post-procedural care and the training video entitled PVS Post Procedure Care.