BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P150012 · Decision Apr 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
    PMA Number
    P150012
    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
    April 25, 2016
    Date Received
    March 3, 2015
    Expedited Review
    N
    Docket Number
    16M-1222

    Advisory Committee Statement

    Approval for The ImageReady MR Conditional Pacing System. The device is indicated for the treatment of the following conditions:1) Symptomatic paroxysmal or permanent second- or third-degree AV block;2) Symptomatic bilateral bundle branch block;3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block);4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity.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:1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block;2) VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm; and3) Low cardiac output or congestive heart failure secondary to bradycardia. Passive-fixation Non-MRI Models 7631, 7632, 7635 and 7636 and MRI Models 7731, 7732, 7735 and 7736 are indicated for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator.Active-fixation Non-MRI Models 7640, 7641, and 7642 and MRI Models 7740, 7741, and 7742 are indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.The intended use of the slit suture sleeve accessory is to secure and immobilize Boston Scientific Ingevity leads at the venous entry site.The delivery stylet accessory is indicated for use with Boston Scientific implantable transvenous leads.

    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)