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Medtronic Puerto Rico Operations Co. MARCS-CMS 562437 —

Medical Devices

Recipient Name
Omar S. Ishrak
Recipient Title
Chief Executive Officer
Medtronic Puerto Rico Operations Co.

710 Medtronic Parkway
Minneapolis, MN 55432
United States

Issuing Office:
Office of Medical Device and Radiological Health Operations Division 2

United States

(407) 475-4700

Dear Mr. Ishrak:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 562437. 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
Compliance Officer
Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 – Central
Minneapolis District

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