BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P090013 · Supplement: S105 · Decision Dec 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    REVO DR MRI RVDR01
    PMA Number
    P090013
    Supplement Number
    S105
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 6, 2013
    Date Received
    June 11, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF LABELING CHANGES TO REMOVE THE RESTRICTION STATING THAT THE PATIENT MUST BE POSITIONED WITHIN THE BORE SUCH THAT THE ISOCENTER (CENTER OF THE MRI BORE) IS SUPERIOR TO THE C1 VERTEBRA OR INFERIOR TO THE T12 VERTEBRA AS WELL AS TO REMOVE THE REQUIREMENT THAT MRI SCANS NOT BE PERFORMED ON PATIENTS WITH OTHER PREVIOUSLY IMPLANTED MEDICAL DEVICES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)