BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Tendyne™ Apical Pad

    Reg #: 3014918977 · FEI: 3014918977 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Medical Costa Rica Limitada (Structural Heart)
    Registration Number
    3014918977
    FEI Number
    3014918977
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    PMA Number
    P240042

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    Alessandra Chaves Sr Manager Structural Heart
    Contact Name
    Alessandra Chaves
    Address
    One Lillehei Plaza
    City
    Little Canada
    State
    MN
    ZIP
    55117
    Country
    US
    Email
    [email protected]
    Phone
    651 9555337

    Products

    Device Name Product Code
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU

    Proprietary Names

    Tendyne™ Apical Pad Tendyne™ Stand Components Tendyne™ Pad Positioning System Tendyne™ Weight Tendyne™ Mitral Valve Tendyne™ Delivery System Tendyne™ Loading System Tendyne™ Stand Tendyne™ Retrieval System

    Establishment Types

    Manufacture Medical Device