BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P960013 · Supplement: S018 · Decision Jun 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    TENDRIL ST LEAD MODELS 1888TC AND 1882TC
    PMA Number
    P960013
    Supplement Number
    S018
    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
    June 6, 2006
    Date Received
    April 13, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE LEAD INSULATION ON THE TENDRIL ST 1788T/TC AND TENDRIL ST 1782 LEADS, AND TO REDUCE THE OUTER COIL WIRE DIAMETER ON THE TENDRIL ST 1782 LEAD. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST LEAD MODEL 1888TC AND TENDRIL ST LEAD MODEL 1882TC. THE TENDRIL ST LEAD MODEL 1888TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST LEAD MODEL 1882TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.

    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