BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Supplement: S039 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK RELIANCE/RELIANCE S STEROID ELUTING EXTENDABLE/RETRACTABLE HELIX ENDOCARDIAL DEFIBRILLATION LEAD
    PMA Number
    P910073
    Supplement Number
    S039
    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
    July 25, 2002
    Date Received
    March 11, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFIED ACTIVE FIXATION DEFIBRILLATION LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENDOTAK RELIANCE AND RELIANCE/S LEADS AND IS INDICATED FOR PACING AND RATE-SENSING AND TO DELIVER CARDIOVERSION AND DEFIBRILLATION SHOCKS FOR AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS.

    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)