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

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S408 · 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
    S408
    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

    ADDITION OF A SPECIFIC ACCEPTANCE CRITERION TO ALLOW DELAMINATION FOR THE LOWER WIRE BONDPAD ON THE U31 FET; 2) TWO PROCESS ADJUSTMENT CHANGES FOR THE INTEGRATED CIRCUIT AT MEDTRONIC SUPPLIER3) THE IMPLEMENTATION OF ADDITIONAL TOOLING FOR THE CASE LINER ASSEMBLY MANUFACTURINGPROCESS; 4) A CHANGE TO THE HYBRID CD SURGE MANUFACTURING TEST SOFTWARE; 5) THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT DEVICES, CORRECTIONS TO THESUBJECT SYSTEMS' BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES,AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS; AND6) THE IMPLEMENTATION OF ADDITIONAL LASER WELDERS TO INCREASE MANUFACTURING CAPACITY.

    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)