BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Saline Implants

    Reg #: 1645337 · FEI: 1000118360 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MENTOR
    Registration Number
    1645337
    FEI Number
    1000118360
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3041 SKYWAY CIRCLE NORTH
    City
    IRVING
    State
    TX
    ZIP
    75038
    Country
    US

    Regulatory Submissions

    PMA Number
    P990075

    Owner / Operator

    Firm Name
    MENTOR Texas, LP
    Operator Number
    2125050
    Address
    3041 Skyway Cir N, --
    City
    Irving
    State
    TX
    Postal Code
    75038
    Country
    US
    Correspondent
    Debra Smith

    Products

    Device Name Product Code
    Prosthesis, Breast, Inflatable, Internal, Saline FWM

    Proprietary Names

    Saline Implants Spectrum Saline Implants Siltex Contour Profile Saline Implants

    Establishment Types

    Manufacture Medical Device