BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xience XPEDITION RX Drug Eluting Stent System

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    2011171
    FEI Number
    2011171
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4900 Gifford Ave
    City
    Los Angeles
    State
    CA
    ZIP
    90058
    Country
    US

    Regulatory Submissions

    PMA Number
    P110019

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Coronary Drug-Eluting Stent NIQ

    Proprietary Names

    Xience XPEDITION RX Drug Eluting Stent System Xience XPEDITION OTW Drug Eluting Stent System Xience Xpedition OTW SV Xience Alpine OTW Xience Xpedition RX Xience Xpedition OTW LL Xience Prime LL Xience Xpedition OTW Xience Xpedition RX LL Xience Prime Xience Alpine RX Xience Xpedition RX SV XIENCE Sierra RX

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)