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

    PMA: P010031 · Supplement: S431 · Decision Apr 4, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D
    PMA Number
    P010031
    Supplement Number
    S431
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 4, 2014
    Date Received
    March 7, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.