BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Ascendra+ Delivery System

    Reg #: 3007063218 · FEI: 3007063218 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd
    Registration Number
    3007063218
    FEI Number
    3007063218
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Changi North Crescent
    City
    Changi South East
    Country
    SG

    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

    US Agent

    Business Name
    EDWARDS LIFESCIENCES LLC
    Contact Name
    Denny Kouri Kouri
    Address
    ONE EDWARDS WAY
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 2506827

    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