BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S077 · Decision Jun 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5
    PMA Number
    P910023
    Supplement Number
    S077
    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 17, 2005
    Date Received
    April 12, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ICD FIRMWARE VERSION 6.6.7 FOR EPIC MODELS V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, EPIC PLUS MODELS V-236, V-196, ATLAS AND ATLAS PLUS MODELS V-242, V243, V-193, V-193C, V340, V-343; AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5.

    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