INSIGNIA Plus and NEXUS Plus

  • Modèle / numéro de série
    INSIGNIA Plus SR (model 1194) serial no. 107477 - 123441; NEXUS Plus SR (model 1394) serial no. 100072 - 100130. INSIGNIA Plus DR (model 1297) serial no. 282034 - 294735; (model 1298) serial no. 128040 - 889944; NEXUS Plus DR (model 1467) serial no. 100011 - 100060; (model 1468) serial no. 100090 - 100276.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, Reunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela
  • Description du dispositif
    Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. || Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA