BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S108 · Decision May 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM
    PMA Number
    P950037
    Supplement Number
    S108
    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 17, 2012
    Date Received
    April 5, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A COPPER ALLOY SHIELDING PLATE TO BE APPLIED OVER THE HOUSING OF A QUARTZ CRYSTAL ON THE PCB AND UPDATE THE DEVICE LABELING. THE PURPOSE FOR THESE MODIFICATIONS IS TO IMPROVE PERFORMANCE DURING RF CAUTERY.

    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