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

    PMA: P010012 · Supplement: S388 · Decision Jun 4, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I
    PMA Number
    P010012
    Supplement Number
    S388
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 4, 2015
    Date Received
    May 18, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.