BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AGENT Paclitaxel-Coated Balloon Catheter

    Reg #: 1225687 · FEI: 3001451463 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
    Registration Number
    1225687
    FEI Number
    3001451463
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    500 Commander Shea Boulevard
    City
    QUINCY
    State
    MA
    ZIP
    02171
    Country
    US

    Regulatory Submissions

    PMA Number
    P230035

    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
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter OOB

    Proprietary Names

    AGENT Paclitaxel-Coated Balloon Catheter

    Establishment Types

    Manufacture Medical Device