BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bulkamid Urethral Bulking System

    Reg #: 3002968685 · FEI: 3002968685 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    P170023

    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
    Agent, Bulking, Injectable For Gastro-Urology Use LNM

    Proprietary Names

    Bulkamid Urethral Bulking System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility