BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ascendra+ Delivery System

    Reg #: 2015691 · FEI: 2015691 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES LLC
    Registration Number
    2015691
    FEI Number
    2015691
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ONE EDWARDS WAY
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    PMA Number
    P130009

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    Products

    Device Name Product Code
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    Ascendra+ Delivery System Crimp Stopper Ascendra + Introducer Sheath Set Edwards SAPIEN XT Transcatheter Heart Valve Ascendra+ System NovaFlex+ System Edwards Crimper Qualcrimp crimping accessory Edwards Expandable Introducer Sheath Set NovaFlex + Delivery System Edwards Dilator Kit

    Establishment Types

    Manufacture Medical Device