BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amplia MRI CRT-D SureScan

    Reg #: 3003120897 · FEI: 3003120897 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Registration Number
    3003120897
    FEI Number
    3003120897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4340 Swinnea Road
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    PMA Number
    P010031

    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
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Pulse Generator, Permanent, Implantable NVZ
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Programmer, Pacemaker KRG
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pacemaker/Icd/Crt Non-Implanted Components OSR

    Proprietary Names

    Amplia MRI CRT-D SureScan Brava Quadripolar CRT-D Compia MRI Quad CRT-D SureScan Viva Protecta CRT-D Concerto ICD Consulta ICD Consulta DF4 ICD Claria MRI Quad CRT-D Viva XT CRT-D Claria MRI CRT-D Brava Viva S CRT-D Compia MRI CRT-D SureScan Amplia MRI Quad CRT-D SureScan Concerto II CRT-D Viva Quad S CRT-D Maximo II CRT-D Viva Quad XT CRT-D Protecta XT CRT-D Cobalt HF CRT-D MRI SureScan Crome HF CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan

    Establishment Types

    Manufacture Medical Device