BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S325 · Decision Jul 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADVISA, ENRHYTHM MRI
    PMA Number
    P980035
    Supplement Number
    S325
    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 15, 2013
    Date Received
    May 13, 2013
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.

    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