BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P010031 · Supplement: S089 · Decision Jan 16, 2008
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ENRHYTHM
    PMA Number
    P010031
    Supplement Number
    S089
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 16, 2008
    Date Received
    December 17, 2007
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE MANUFACTURING PROCESS FOR THE BOND PAD ARRAY (BPA) COMPONENTS FROM PRESS-FIT TO INSERT-MOLDED.