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CLOSEOUT LETTER

American Medical Systems, LLC


American Medical Systems, LLC

 

  

Black HHS-Blue FDA Logo

 

Office of Medical Devices and Radiological Health Operations (OMDRHO), Division 2 - Central
555 Winderley Place, Suite 200
Maitland, FL 32751
(407) 475-4700 

 
 

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.

Sincerely,
/S/

Timothy G. Philips
Compliance Officer
Minneapolis District