BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SJM Regent™ Mechanical Heart Valve

    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
    P810002

    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
    Heart-Valve, Mechanical LWQ

    Proprietary Names

    SJM Regent™ Mechanical Heart Valve SJM™ Masters Series Aortic Valved Graft with Hemashield™ graft technology SJM Aortic Valved Graft Masters Series™ Mechanical Heart Valve SJM Masters HP Series Valved Graft with Gelweave Valsalva™ technology Regent™ Mechanical Heart Valve St. Jude Mechanical Heart valve SJM™ Masters Series Mechanical Heart Valve Masters Series™ Aortic Valved Graft with Hemashield‡ graft technology Mechanical Valved Graf

    Establishment Types

    Manufacture Medical Device