BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SJM Regent™ Mechanical Heart Valve

    Reg #: 2135147 · FEI: 3005334138 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    2135147
    FEI Number
    3005334138
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5050 NATHAN LANE NORTH
    City
    Plymouth
    State
    MN
    ZIP
    55442
    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

    Complaint File Establishment per 21 CFR 820.198