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

    PMA: P010031 · Supplement: S291 · Decision Mar 9, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PROTECTA CRT-D, PROTECTA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S291
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 9, 2012
    Date Received
    February 13, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.