BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980035 · Supplement: S010 · Decision May 14, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC KAPPA 700/600 PULSE GENERATOR
    PMA Number
    P980035
    Supplement Number
    S010
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 14, 2001
    Date Received
    April 13, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE EPOXY APPLICATION PATTERN AND A WIRE BOND LOOP PROGRAM IN THE ABOVE REFERENCED FAMILY OF PULSE GENERATORS.