- American Medical Systems, LLC
- Issuing Office:
Office of Medical Devices and Radiological Health Operations (OMDRHO), Division 2 - Central
August 25, 2017
Catherine K. Olson
Vice President of Minnetonka Operations
American Medical Systems, LLC
A wholly-owned indirect subsidiary of:
Boston Scientific Corporation
10700 Bren Rd West
Minnetonka, MN 55343
Dear Ms. Olson:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter MN 14-17. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
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.
Timothy G. Philips