BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 2182208 · FEI: 2182208 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTRONIC, INC.
    Registration Number
    2182208
    FEI Number
    2182208
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8200 Coral Sea Street NE
    City
    Mounds View
    State
    MN
    ZIP
    55112
    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

    Develop Specifications But Do Not Manufacture At This Facility