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NOTES TM May 28th and 29th October 1st and 2nd Natural Orifice Advanced courses Transluminal Endoscopic Surgery 2010 REGISTRATION FORM Dr./Prof. Family name. First name. . . . . . . . . . . . . .

Address 2. First name Address 3 Address 4 City/State State Zip Country Country Email Message Dear Dr As you are probably aware, the FDA is currently investigating an allegation that you engaged in certain conduct which can reasonably be considered to be contrary to law or regulation. As a result, the FDA has filed a proposed order with the Secretary of Health and Human Services for preliminary findings pursuant to 31 U.S.C. § 335(b). FDA believes that, based on its review of your clinical and research records, that your practice of teaching and performing Transluminal Endoscopic Surgery (TES) may be in violation of FDA regulations. We also believe that your practice of teaching and performing TES may be in violation of other applicable laws and regulations as well. As such, FDA requests that you immediately cease all future teaching or performing of TES while such a violation is under investigation. In particular, FDA requests that you immediately stop performing any of your current Clinical Research procedures using the Transluminal TES system until such time that you properly comply with FDA's request; that you promptly provide FDA with the medical records of all of your current Clinical Research patients; and that you provide a written report to FDA describing the changes to your procedure that you are required to make during the investigation (which report must be submitted within 20 calendar days after the end of the investigation). FDA would like to talk with you about the specifics of your current procedures and the basis for changes made after your current activities were documented. If you are willing to talk now with FDA about your current practices, and to explain the basis for any changes, FDA can provide your name and contact information, the results of any ongoing surveillance investigations, as well as any relevant scientific data (i.e., clinical trials) that may be required for any future regulatory action. We will not, however, be able to provide you with copies of the documentation we have on file for you until such time as any investigation is completed. This letter is being sent in response to your recent letter in support of your request. At this time, FDA cannot tell you the name of any individual clinical trial that you are enrolled in that may have been affected by this investigation.

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