BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P010031 · Supplement: S222 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CONCERTO II, CONSULTA AND MAXIMO II
    PMA Number
    P010031
    Supplement Number
    S222
    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
    March 22, 2011
    Date Received
    December 7, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;

    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