BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S073 · Decision Oct 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    INTERSTIM THERAPY FOR URINARY CONTROL
    PMA Number
    P970004
    Supplement Number
    S073
    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
    October 26, 2009
    Date Received
    April 28, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE EXISTING MODEL 3093 AND MODEL 3889 INTERSTIM TINED LEADS, THE ADDITION OF AN ALTERNATIVE STYLET DESIGN TO BE INCLUDED IN THE MODEL 3093 AND MODEL 3889 LEADS KITS, AND A MINOR REVISION TO THE LABELING TO UPDATE THE LIST OF PACKAGE CONTENTS FOR THE MODEL 3093 AND MODEL 3889 LEADS KITS.

    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