BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AeroPace System

    Reg #: 3014139597 · FEI: 3014139597 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LUNGPACER MEDICAL USA, INC.
    Registration Number
    3014139597
    FEI Number
    3014139597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    260 Sierra Dr Ste 116
    City
    Exton
    State
    PA
    ZIP
    19341
    Country
    US

    Regulatory Submissions

    PMA Number
    P240012

    Owner / Operator

    Firm Name
    Lungpacer Medical USA, Inc.
    Operator Number
    10092127
    Address
    260 Sierra Drive, Suite 116
    City
    Exton
    State
    PA
    Postal Code
    19341
    Country
    US
    Correspondent
    Judy P Ways

    Products

    Device Name Product Code
    Transvenous Temporary Phrenic Nerve Stimulator SDL

    Proprietary Names

    AeroPace System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198