BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: N970003 · Decision Jun 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
    PMA Number
    N970003
    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
    June 3, 1999
    Date Received
    September 8, 1997
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR YOUR PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE:GUIDANT PULSAR MODELS 470, 970, 972, 1172, 1272 PULSE GENERATORS, GUIDANT PULSAR MAX MODELS 1170, 1171, 1270 PULSE GENERATORS, AND GUIDANT CONSULT (MODEL 2890) SOFTWARE.GUIDANT PULSAR/PULSAR MAX SERIES PACEMAKERS ARE INDICATED FOR THE FOLLOWING: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND. OR THIRD-DEGREE AV BLOCK SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCKSYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS (EG, SINUS BRADYCARDIA, SINUS ARREST, SINOATRIAL [SA] BLOCK) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS NEUROVASCULAR (VASOVAGAL) SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES ADAPTIVE-RATE PACING IS INDICATED FOR PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR LEVEL OF PHYSICAL ACTIVITY. THE PULSAR¿/PULSAR MAX¿ SERIES PACEMAKERS' DUAL CHAMBER AND ATRIAL TRACKING MODES ARE ALSO INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF THE FOLLOWING:CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF AV SYNCHRONY, INCLUDING VARYING DEGREES OF AV BLOCK VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM LOW CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE SECONDARY TO BRADYCARDIA.

    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)