BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S579 · Decision Sep 7, 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 Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1D4,Evera MRI S DR SureScan Model DDMC3D4, Ev
    PMA Number
    P980016
    Supplement Number
    S579
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 7, 2016
    Date Received
    March 11, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.

    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)