BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Axonics Rechargeable Sacral Neuromodulation System

    Reg #: 2124215 · FEI: 2124215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    2124215
    FEI Number
    2124215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4100 Hamline Ave N
    City
    Saint Paul
    State
    MN
    ZIP
    55112
    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

    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

    Complaint File Establishment per 21 CFR 820.198