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

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    PMA: P080025 · Supplement: S216 · Decision Nov 30, 2020
    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, Verify Evaluation System (SNS Urinary)
    PMA Number
    P080025
    Supplement Number
    S216
    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
    November 30, 2020
    Date Received
    November 3, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of Meier Tool & Engineering (Meier Tool), Anoka, MN - USA as an alternate supplier for a battery component (second source) for the uncoated battery cathode current collector that is consumed into titanium coated cathode current collectors and eventually into the Delta 26H2 and Delta 26H3 medium rate batteries further used in implantable neurostimulators. And the addition of Incoming Inspection Procedures for Uncoated and Coated Cathode Current Collector Components Originating from Meier Tool.

    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