BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S890 · Decision Apr 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    Cobalt XT MRI ICD
    PMA Number
    P980016
    Supplement Number
    S890
    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
    April 26, 2024
    Date Received
    March 28, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of new patient enrollment closure for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P010031/S674.

    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)