BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P010015 · Supplement: S125 · Decision Jul 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    SYNCRA/CONSULTA CRT-P
    PMA Number
    P010015
    Supplement Number
    S125
    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 1, 2011
    Date Received
    May 19, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF MODIFICATION TO THE 2490G SOFTWARE REQUIREMENTS SPECIFICATION TO ADD THE CRT-P DEVICE MODEL NUMBERS TO THE AUTO-ID LIST FOR THE MODEL 2020A CARDIOSIGHT READER.

    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