BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S031 · Decision Feb 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE
    PMA Number
    P010012
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 9, 2005
    Date Received
    August 18, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF WANDLESS TELEMETRY TO YOUR CURRENTLY MARKET-APPROVED CRT-D DEVICES THAT WILL ALLOW COMMUNICATION WITH THE PROGRAMMER AT AN INCREASED DISTANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL 3 RF AND IS INDICATED FOR THE FOLLOWING: THE CONTAK RENEWAL 3 RF CRT-D IS INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)