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

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    PMA: P190006 · Supplement: S017 · Decision Jul 10, 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
    Axonics Sacral Neuromodulation System
    PMA Number
    P190006
    Supplement Number
    S017
    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 10, 2020
    Date Received
    June 12, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Axonics Charging Device uses a printed circuit board assembly (PCBA) that is currently tested manually using test procedure, 120-0113 (VOL# 27, file #009 of original submission). To support an increase in production, Axonics developed a test fixture (# 200-0198-001, built with software 150-0113-001) that automates the tests that are in the original manual test procedure. A complete traceability of test steps in the original manual test procedure to the proposed automated test fixture requirements is provided.

    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