BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Supplement: S041 · Decision Nov 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD
    PMA Number
    P910073
    Supplement Number
    S041
    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
    November 4, 2003
    Date Received
    March 4, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE ACTIVE AND PASSIVE FIXATION ENDOTAK FAMILY OF DEFIBRILLATION LEADS AND TO PACKAGE THE LEADS WITH A TRANSVALVULAR INSERTION TOOL FOR USE WITH A HEMOSTATIC INTRODUCER. THE LEADS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G ENDOCARDIAL DEFIBRILLATION LEAD, MODELS 0164, 0165, 0166, 0167, 0174, 0175, 0176, 0177 AND ENDOTAK RELIANCE SG ENDOCARDIAL DEFIBRILLATION LEAD, MODELS 0160, 0161, 0162, 0163.

    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)