BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AGENT Paclitaxel-Coated Balloon Catheter

    Reg #: 2124215 · FEI: 2124215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    2124215
    FEI Number
    2124215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4100 Hamline Ave N
    City
    Saint Paul
    State
    MN
    ZIP
    55112
    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

    Complaint File Establishment per 21 CFR 820.198