BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Axonics Rechargeable Sacral Neuromodulation System

    Reg #: 3002968685 · FEI: 3002968685 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AXONICS, INC.
    Registration Number
    3002968685
    FEI Number
    3002968685
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15515 Sand Canyon Ave
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    PMA Number
    P190006

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Adrienne Bishop

    Products

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

    Proprietary Names

    Axonics Rechargeable Sacral Neuromodulation System Axonics Axonics Therapy Axonics r-SNM System Axonics SNM System Axonics Therapy for Bowel Control Foramen Finder Axonics SNM Therapy Axonics Sacral Neuromodulation Therapy Axonics System Axonics Sacral Neuromodulation System

    Establishment Types

    Manufacture Medical Device