BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Edwards SAPIEN 3 Transcatheter Heart Valve

    Reg #: 3017298588 · FEI: 3017298588 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Edwards Lifesciences Ireland Limited
    Registration Number
    3017298588
    FEI Number
    3017298588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    National Technology Park, Castletroy
    City
    Limerick Munster
    Country
    IE

    Regulatory Submissions

    PMA Number
    P200015

    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

    US Agent

    Business Name
    Edwards Lifesciences
    Contact Name
    Denny Kouri
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 2502500

    Products

    Device Name Product Code
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV

    Proprietary Names

    Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System Edwards Crimper Edwards SAPIEN 3 Transcather Pulmonary Valve System with Alterra Adaptive Prestent Edwards SAPIEN 3 Pulmonic Delivery System

    Establishment Types

    Manufacture Medical Device