BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medtronic CoreValve System

    Reg #: 2025587 · FEI: 2025587 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medtronic Heart Valves Division
    Registration Number
    2025587
    FEI Number
    2025587
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1851 EAST DEERE AVE.
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Regulatory Submissions

    PMA Number
    P130021

    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
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO System CoreValve Evolut PRO+ System Medtronic Evolut FX System Evolut FX+ System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility