BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P900061 · Supplement: S057 · Decision Oct 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
    PMA Number
    P900061
    Supplement Number
    S057
    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
    October 20, 2005
    Date Received
    September 16, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.

    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)