BEUDAMED
    FDA Registration Active 🇮🇳 India

    Protecta XT CRT-D

    Reg #: 3018094310 · FEI: 3018094310 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Medtronic Engineering and Innovation Center (MEIC)
    Registration Number
    3018094310
    FEI Number
    3018094310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BSR Tech Park, Survey No.135, 138, 141 & 142 Nanakramguda Main Road
    City
    Hyderabad
    Country
    IN

    Regulatory Submissions

    PMA Number
    P980016

    Owner / Operator

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

    US Agent

    Business Name
    MEDTRONIC, INC.
    Contact Name
    Tania Pearson
    Address
    3576 Unocal Pl
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US
    Email
    [email protected]
    Phone
    916 8138456

    Products

    Device Name Product Code
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Pulse Generator, Permanent, Implantable NVZ

    Proprietary Names

    Protecta XT CRT-D Intrinsic ICD Visia AF MRI S VR SureScan Protecta XT DR Evera MRI XT DR SureScan Evera MRI XT VR SureScan CareLink Network Software Protecta XT VR Maximo II DR Visia AF VR Evera S DR Protecta DR Marquis DR ICD Protecta VR Evera MRI S DR SureScan Marquis VR ICD EnTrust ICD Secura VR Maximo II VR Maximo DR ICD Secura DR Maximo VR ICD Evera Evera S VR Evera MRI S VR Medtronic Longevity Virtuoso II DR/VR ICD Evera XT VR Visia AF MRI VR SureScan Evera XT DR Primo MRI DR SureScan Primo MRI VR SureScan Crome DR MRI Surescan Cobalt DR MRI Surescan Cobalt VR MRI Surescan Cobalt XT DR MRI Surescan Crome VR MRI Surescan Cobalt XT VR MRI Surescan

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198