BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P880086 · Supplement: S204 · Decision Jun 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    SUSTAIN XL FAMILY OF PACEMAKERS
    PMA Number
    P880086
    Supplement Number
    S204
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 8, 2011
    Date Received
    May 6, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE NEW SUSTAIN XL PACEMAKER MODELS, PREDICATED OFF THE VICTORY/ZEPHYR FAMILY OF PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUSTAIN XL DR/SR AND SUSTAIN XL DC/SC AND IS INDICATED FOR INDICATIONS AND USAGE: IMPLANTATION OF SUSTAIN PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO:1) SYNCOPE2) PRESYNCOPE3) FATIGUE4) DISORIENTATION5) OR ANY COMBINATION OF THOSE SYMPTOMS.RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY. DUAL-CHAMBER PACING (MODELS PM2134 AND PM2136 ONLY) IS INDICATED FOR THOSE PATIENTS EXHIBITING:1) SICK SINUS SYNDROME2) CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK3) RECURRENT ADAMS-STOKES SYNDROME4) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV ANDINTRAVENTRICULAR CONDUCTION SYSTEMS.VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:1) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST2) CHRONIC ATRIAL FIBRILLATION3) SEVERE PHYSICAL DISABILITY.AF SUPPRESSION (MODELS PM2134 AND PM2136 ONLY) IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable