BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S143 · Decision Jul 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
    PMA Number
    P910077
    Supplement Number
    S143
    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
    July 16, 2014
    Date Received
    May 27, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE WAVE COMMUNICATOR MODEL 6280 SW VERSION V1.52.00;WAVE COMMUNICATOR MODEL 6290 SW VERSION V2.02.00;WAVE COMMUNICATOR MODEL 6498 SW VERSION V1.52.00;LATITUDE NXT SYSTEM SOFTWARE MODEL 6460 V.3.00.01; ANDCOMMUNICATOR ACCESSORY AND LITERATURE KIT MODEL 6250.

    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)