BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Decision May 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    TVL(TM) LEAD SYSTEM
    PMA Number
    P950022
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 10, 1996
    Date Received
    June 30, 1995
    Expedited Review
    N
    Docket Number
    97M-0460

    Advisory Committee Statement

    APPROVAL FOR THE VENTRITEX TVL LEAD SYSTEM:TRANSVENOUS RIGHT VENTRICULAR LEAD MODELS RV-1101, RV01, AND RV02; TRANSVENOUS SUPERIOR VENA CAVA LEAD MODELS, SV-1101, SV01, SV02, AND SV03; SUBCUTANEOUS LEAD MODELS, SQ-701 AND SQ01; VEIN PICK MODEL TV-0001; SILICONE LUBRICANT MODEL TV-0013; LEAD TUNNELER KIT MODEL LTK-01; MODEL AC-2481 HIGH VOLTAGE Y-ADAPTER; MODEL AC-CDT-EX VENTRITEX EXTERNAL STIMULATOR ADAPTER; AND TVL LEAD SYSTEM ACCESSORY KIT

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

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