BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tendyne™ Apical Pad

    Reg #: 3007113487 · FEI: 3007113487 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3007113487
    FEI Number
    3007113487
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    177 County Road B East
    City
    Saint Paul
    State
    MN
    ZIP
    55117
    Country
    US

    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

    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