BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AXONICS, INC.

    Reg #: 3002968685 · FEI: 3002968685 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    AXONICS, INC.
    Registration Number
    3002968685
    FEI Number
    3002968685
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    15515 Sand Canyon Ave
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    PMA Number
    P180046

    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
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Agent, Bulking, Injectable For Gastro-Urology Use LNM
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON

    Proprietary Names

    Axonics System Axonics Sacral Neuromodulation System Axonics SNM Therapy Foramen Finder Axonics r-SNM System Axonics Therapy Axonics Axonics Therapy for Urinary Control Axonics Sacral Neuromodulation Therapy Axonics SNM System Axonics Rechargeable Sacral Neuromodulation System Bulkamid Urethral Bulking System Axonics Therapy for Bowel Control

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility