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Olympus Medical Systems Corporation MARCS-CMS 546986 —

Medical Devices

Recipient Name
Julien Sauvagnargues
Recipient Title
President & CEO
Olympus Medical Systems Corporation

3500 Corporate Parkway
Center Valley, PA 18034
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Julien Sauvagnargues:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546986, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
Courtney H. Lias, Ph.D.
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Center for Devices and Radiological Health

Laura Storms
Vice President, Regulatory Affairs & Quality Assurance
Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley, Pennsylvania 18034

Kota Nozue
Postmarket Surveillance Project Leader
3500 Corporate Parkway P.O. Box 610
Center Valley, Pennsylvania 18034

Akihiro Okubo, President
Olympus Medical Systems Corporation
2951 Ishikawa-cho, Hachioji-shi
Tokyo 192-8507, Japan

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