BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S121 · Decision May 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T
    PMA Number
    P950037
    Supplement Number
    S121
    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
    May 8, 2013
    Date Received
    April 3, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.

    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