BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optisure High Voltage Lead Family

    Reg #: 2938836 · FEI: 2938836 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    2938836
    FEI Number
    2938836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    645 Almanor Ave
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    PMA Number
    P950022

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY

    Proprietary Names

    Optisure High Voltage Lead Family Durata, Durata DF4 Transvenous Defibrillation Leads

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198