BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Edwards SAPIEN 3 Transcatheter Heart Valve

    Reg #: 2015691 · FEI: 2015691 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    2
    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
    P140031

    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
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU

    Proprietary Names

    Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Crimper Edwards Commander Delivery System Edwards Certitude Delivery System Edwards Certitude Introducer Sheath Edwards Certitude Introducer Sheath Set Edwards SAPIEN 3 Ultra Transcatheter Heart Valve eSheath- 916ES eSheath- 914ES Edwards eSheath Introducer Set- 914ES Edwards eSheath Introducer Set- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device