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Atrium tdoc implementation guide

Atrium Medical Corporation Noti ?cation Guide Certi ?cate of Medical Necessity Form FEBRUARY FOR US CUSTOMERS ONLY CContents Overview Restricted Products Restricted Products Available with Certi ?cate of Medical Necessity Other MAQUET Company Products Available without Restriction Submitting a Certi ?cate of Medical Necessity Appendix Certi ?cate of Medical Necessity CMN Form Appendix Atrium Contact Information FOR US CUSTOMERS ONLY C Overview This Noti ?cation Guide provides information about changes in the availability of certain products made by Atrium Medical Corporation Atrium as a result of our entry into a civil Consent Decree Decree with the U S Department of Justice DOJ on behalf of the U S Food and Drug Administration FDA This guide also provides information on how to maintain continued supply of the Atrium products you are currently using including how to submit a Certi ?cate of Medical Necessity CMN see Section on page If you have questions about the availability of Atrium products please call your local sales representative In addition because we have created a website for you to be kept informed about this issue please visit www atriummed com consentdecree for more information Background Atrium along with three other a ?liated MAQUET companies entered into a Decree with the U S Government that was approved by the Court on February The Decree addresses concerns raised by FDA during inspections of Atrium and other MAQUET manufacturing facilities conducted in The government concluded that Atrium and MAQUET had violated the Federal Food Drug and Cosmetic Act by manufacturing and selling devices that were not in conformity with FDA ? s current Good Manufacturing Practices and quality system regulations We started making corrections to our facilities in and they are well underway Under the Decree manufacturing operations at Atrium facilities in Hudson New Hampshire will be temporarily suspended with regard to certain products while corrections are being made Atrium specializes in manufacturing medical devices for the treatment of coronary and vascular disease tracheal bronchial management chest trauma hernia and soft tissue injury Atrium may continue to distribute certain products inside and outside of the U S that are deemed medically necessary under the Decree provided that the authorized representatives of U S and International customers have signed the attached CMN form certifying that after learning from this Noti ?cation Guide of the FDA ?ndings at the Atrium Hudson manufacturing facility and evaluating the relevant risks and bene ?ts there is an immediate medical need for the continued use and purchase of these products Some other products manufactured by Atrium will be temporarily unavailable once existing inventory located at our distribution facilities has been exhausted Other MAQUET companies inside and outside of the U S will continue to produce and distribute products globally without interruption FOR US CUSTOMERS ONLY C Restricted Products Under the terms of the Decree the following products manufactured at Atrium ? s Hudson New Hampshire facilities will be unavailable until further notice except to the extent that these products are in current inventory at