BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Edwards Lifesciences

    Reg #: 3015287573 · FEI: 3015287573 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Edwards Lifesciences
    Registration Number
    3015287573
    FEI Number
    3015287573
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts sur, Finca 31 y 32
    City
    Guadalupe Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K020864
    PMA Number
    P150048

    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
    Heart-Valve, Non-Allograft Tissue LWR
    Ring, Annuloplasty KRH
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Replacement Heart-Valve DYE

    Proprietary Names

    INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis KONECT RESILIA Aortic Valved Conduit MITRIS RESILIA Mitral Valve TRIFORMIS RESILIA Tricuspid Valve EDWARDS MC3 TRICUSPID ANNULOPLASTY RING Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System Edwards Crimper Edwards Certitude Introducer Sheath Edwards Certitude Delivery System Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards eSheath Introducer Set- 914ES eSheath- 914ES Edwards eSheath Introducer Set- 916ES eSheath- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Physio Flex Annuloplasty Ring PHYSIO FLEX Annuloplasty Ring Edwards MC3 Tricuspid Annuloplasty Ring Carpentier-Edwards Perimount Bioprosthesis CARPENTIER-McCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING Cosgrove-Edwards Annuloplasty Ring CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING Carpentier-Edwards Physio Annuloplasty Ring Carpentier-Edwards Physio Ring CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

    Establishment Types

    Manufacture Medical Device