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    FDA Registration Active 🇺🇸 United States

    Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator

    Reg #: 2649622 · FEI: 2649622 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Registration Number
    2649622
    FEI Number
    2649622
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RD. 149, KM. 56.3, Call Box 6001
    City
    Villalba
    State
    PR
    ZIP
    00766
    Country
    US

    Regulatory Submissions

    PMA Number
    P220012

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY

    Proprietary Names

    Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator Epsila EV™ Sternal Tunneling Tool Epsila EV™ MRI SureScan™ extravascular lead AURORA EV-ICD™ MRI SURESCAN™ SW041 Epsila EV™ Transverse Tunneling Tool

    Establishment Types

    Manufacture Medical Device