BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORBERA Intragastric Balloon

    Reg #: 3006722112 · FEI: 3006722112 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    APOLLO ENDOSURGERY INC
    Registration Number
    3006722112
    FEI Number
    3006722112
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1120 S Capital of TX Hwy, Bldg 1, Ste 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US

    Regulatory Submissions

    PMA Number
    P140008

    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
    Implant, Intragastric For Morbid Obesity LTI

    Proprietary Names

    ORBERA Intragastric Balloon

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility