BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    PMA: P080025 · Supplement: S114 · Decision Jul 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
    Trade Name
    INTERSTIM THERAPY SYSTEM
    PMA Number
    P080025
    Supplement Number
    S114
    Device Class
    FDA Class 3
    Product Code
    QON
    Generic Name
    Implanted electrical device intended for treatment of fecal incontinence
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 27, 2016
    Date Received
    June 27, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.

    Classifications

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

    Product Code Device Name
    QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence