BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980049 · Supplement: S002 · Decision Nov 13, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ORCHESTRA PROGRAMMER
    PMA Number
    P980049
    Supplement Number
    S002
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 13, 2000
    Date Received
    July 6, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ORCHESTRA PROGRAMMER WITH THE FOLLOWING APPLICATION SOFTWARE PACKAGES: MANAGER SOFTWARE APPLICATION VERSION 1.02, CSO A PROGRAMMER APPLICATION VERSION 2.21, CSO-WINDOWS PROGRAMMER APPLICATION VERSION 1.03, DEFENDER II PROGRAMMER APPLICATION VERSION 2.03, AND DEFENDER IV PROGRAMMER APPLICATION VERSION 1.03.