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

    PMA: P010012 · Supplement: S396 · Decision Aug 8, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-D
    PMA Number
    P010012
    Supplement Number
    S396
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 8, 2015
    Date Received
    July 13, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD AN ADDITIONAL INSPECTION STEP TO PULSE GENERATOR CASE HALF MANUFACTURING, ALONG WITH ASSOCIATED SPECIFICATION AND INSPECTION CRITERIA, THAT WILL ALLOW PULSE GENERATOR CASE HALF DISCONTINUITIES TO BE DISTINGUISHED FROM DENTS.