Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Polynesia, Portugal, Qatar, Russia, Saint Lucia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, West Indies.
Description du dispositif
VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing).
Worldwide Distribution: All States in the continental USA including PR and DC , but excluding VT, the countries of Canada, Mexico, and in Europe. ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRITISH VIRGIN ISLANDS, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, PORTUGAL , QATAR, SAINT KITTS & NEOIS, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM,VENEZUELA, URUGUAY, ZIMBABWE, IRAN.