BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Attain Bipolar OTW Lead

    Reg #: 2649622 · FEI: 2649622 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    4

    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
    P010015

    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 Pulse Generator, Pacemaker (Non-Crt) LWP
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Pulse Generator, Permanent, Implantable NVZ

    Proprietary Names

    Attain Bipolar OTW Lead Attain Syncra CRT-P Consulta CRT-P Serena Quad CRT-P MRI SureScan Attain OTW Insync Viva CRT-P Percepta Quad CRT-P MRI SureScan Solara Quad CRT-P MRI SureScan Solara CRT-P MRI SureScan Percepta CRT-P MRI SureScan Serena CRT-P MRI SureScan CareLink SmartSync Percepta, Solera, Serena Application

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device