BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P030035 · Supplement: S037 · Decision Dec 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    FRONTIER/FRONTIER II FAMILY OF CRT-PS
    PMA Number
    P030035
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    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
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)