BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910023 · Supplement: S056 · Decision Oct 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
    PMA Number
    P910023
    Supplement Number
    S056
    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 15, 2001
    Date Received
    September 17, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR UPDATES TO THE DEVICE SOFTWARE FOR THE PHOTON DR ICD (MODEL V-230HV) AND THE PHOTON MICRO (U) VR/DR ICDS (MODELS V-194/V-232) AND MINOR UPDATED TO THE PROGRAMMER SOFTWARE SUPPORTING THE MODEL 3500 AND MODEL 3510 PROGRAMMERS AS WELL AS THE SOFTWARE SUPPORTING THE PR-1500 AND PR-3500 MODEL PROGRAMMERS.

    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)