BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stellarex Drug-Coated Angioplasty Balloon

    Reg #: 3016257349 · FEI: 3016257349 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Image Guided Therapy Corporation
    Registration Number
    3016257349
    FEI Number
    3016257349
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5905 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    PMA Number
    P160049

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2939520
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU

    Proprietary Names

    Stellarex Drug-Coated Angioplasty Balloon Stellarex 035” OTW Drug-coated Angioplasty Balloon

    Establishment Types

    Manufacture Medical Device