BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optisure High Voltage Lead Family

    Reg #: 3013288201 · FEI: 3013288201 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT MEDICAL
    Registration Number
    3013288201
    FEI Number
    3013288201
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14901 Deveau Pl. Building 2
    City
    Minnetonka
    State
    MN
    ZIP
    55345
    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