BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SynCardia Systems, LLC Total Artificial Heart

    Reg #: 3003761017 · FEI: 3003761017 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SYNCARDIA SYSTEMS, LLC
    Registration Number
    3003761017
    FEI Number
    3003761017
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1992 E Silverlake Rd
    City
    TUCSON
    State
    AZ
    ZIP
    85713
    Country
    US

    Regulatory Submissions

    PMA Number
    P030011

    Owner / Operator

    Firm Name
    SYNCARDIA SYSTEMS, LLC
    Operator Number
    9067898
    Address
    1992 E. SILVERLAKE RD.
    City
    Tucson
    State
    AZ
    Postal Code
    85713
    Country
    US
    Correspondent
    Michael Larsen

    Products

    Device Name Product Code
    Artificial Heart LOZ

    Proprietary Names

    SynCardia Systems, LLC Total Artificial Heart

    Establishment Types

    Manufacture Medical Device