BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S162 · Decision Dec 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CADENCE FAMILY OF ICDS
    PMA Number
    P910023
    Supplement Number
    S162
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 12, 2007
    Date Received
    October 24, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE. FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE. DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS. FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable