BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S054 · Decision May 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01
    PMA Number
    P970004
    Supplement Number
    S054
    Device Class
    FDA Class 3
    Product Code
    EZW
    Generic Name
    Stimulator, electrical, implantable, for incontinence
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 30, 2008
    Date Received
    April 2, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE PROGRAMMING GUIDE FOR MODELS 8840 NVISION CLINICIAN PROGRAMMER AND 8870 NVISION APPLICATION CARD, TO BETTER DESCRIBE HOW TO DETERMINE THE BATTERY STATUS OF THE MODEL 3058 INTERSTIM IMPLANTABLE NEUROSTIMULATOR AND FOR ADDITIONAL MINOR LABELING CHANGES.

    Classifications

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

    Product Code Device Name
    EZW Stimulator, Electrical, Implantable, For Incontinence