BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S079 · Decision Sep 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    RELIATY/MODEL 3145 PACING SYSTEM ANALYZER
    PMA Number
    P950037
    Supplement Number
    S079
    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
    September 2, 2010
    Date Received
    March 23, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A STAND-ALONE VERSION OF THE PACING SYSTEM ANALYZER FUNCTION FOUND IN THE ICS 3000 IMPLANT CONTROL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RELIATY BY BIOTRONIK, INC. AND MODEL 3145 BY BOSTON SCIENTIFIC AND IS INDICATED FOR USE IN PACING LEAD SYSTEM ANALYSIS DURING THE IMPLANTATION OF PACEMAKERS AND DEFIBRILLATORS.

    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