BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P880086 · Supplement: S150 · Decision Jul 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    INDENTITY & IDENTITY ADX FAMILY OF DEVICES
    PMA Number
    P880086
    Supplement Number
    S150
    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
    July 12, 2007
    Date Received
    June 20, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE CIRCUITRY USE DIN THE ANALOG CHIP IN THE VICTORY/ZEPHYR FAMILY OF DEVICES IN THE ANALOG CHIP USED IN THE IDENTITY AND IDENTITY ADX FAMILY OF DEVICES, AND FOR RESIZING THE SENSE AND IEGM GAIN CAPACITORS.

    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