BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTIMIZER Smart System

    Reg #: 3012563838 · FEI: 3012563838 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Impulse Dynamics USA Inc
    Registration Number
    3012563838
    FEI Number
    3012563838
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 Lake Center Executive Parkway, Suite 100, 401 Route 73 N, Bldg. 50
    City
    Marlton
    State
    NJ
    ZIP
    08053
    Country
    US

    Regulatory Submissions

    PMA Number
    P180036

    Owner / Operator

    Firm Name
    Impulse Dynamics USA Inc
    Operator Number
    10032587
    Address
    50 Lake Center Executive Parkway, 401 Route 73 N, Bldg. 50, Suite 100
    City
    Marlton
    State
    NJ
    Postal Code
    08053
    Country
    US

    Products

    Device Name Product Code
    Implantable Pulse Generator QFV

    Proprietary Names

    OPTIMIZER Smart System OPTIMIZER Smart Mini System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility