On February 3, 2015, Atrium and three other affiliated Maquet companies reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement has been approved by a federal judge in New Hampshire and it establishes a framework that provides assurances to FDA that we will complete the improvements currently underway to strengthen our quality management system.

Below is a summary of the steps that you, as the customer, need to take to obtain the products deemed medically necessary by FDA.

To continue to receive medically necessary products:

The Certificate of Medical Necessity (CMN) form must be completed and signed by an authorized representative of the customer certifying that, s/he is aware of FDA’s findings and deems the product necessary.

Certificate of Medical Necessity (CMN) Form US (PDF)

Certificate of Medical Necessity (CMN) Form Outside US (PDF)

Certificate of Medical Necessity (CMN) Form Thai (PDF)

• Customers must provide the completed CMN form to Atrium as soon as possible in order to continue receiving restricted products.
• Please return the completed CMN form to Atrium in one of three ways:
  • PDF: cmn@atriummed.com
  • U.S. Fax: 1-800-880-6976
  • International Fax: Please see this list of country specific fax numbers
  • Mail:
    Office of Medical Affairs
    Atrium Medical Corporation
    5 Wentworth Drive
    Hudson, NH 03051 U.S.A.