BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S409 · Decision May 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    EVERA S DR, EVERA S VR, EVERA XT DR
    PMA Number
    P980016
    Supplement Number
    S409
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 3, 2013
    Date Received
    April 8, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; 2) THE APPROVAL OF MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA; 3) NEW PRESSURE TEST EQUIPMENT TO VERIFY HERMETICITY; 4) MODIFICATIONS TO A CONTROLLED ENVIRONMENT; 5) A CHANGE TO THE DESCUM AND CLEANING PROCESS FOR THE 3UM CMOS INTEGRATED CIRCUIT; AND 6) A NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)