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

    PMA: P010031 · Supplement: S354 · Decision Mar 7, 2013
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)
    PMA Number
    P010031
    Supplement Number
    S354
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 7, 2013
    Date Received
    February 6, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT CRT-D SYSTEMS, CORRECTIONS TO THE SUBJECT SYSTEMS¿ BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES, AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS.