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

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S607 · Decision Nov 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M
    PMA Number
    P980016
    Supplement Number
    S607
    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
    November 14, 2016
    Date Received
    October 19, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Various previously accepted changes to align manufacturing of the Evera MRI and Visia AF DF-1 ICD device models with existing manufacturing, including, 1) Changes to the integrated circuit wafer manufacturing process; 2) an update to the distribution control sorter tool system; 3) updates to the post sterilization test; 4) a change to the suppliers cleaning process for the accelerometer; 5) changes to the wafer manufacturing process; 6) an update to the manufacturing inspection process for feedthrough assemblies; and 7) to update to the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.

    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)