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  5. St. Jude Medical (CardioMEMS) - 480398 - 10/17/2018
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St. Jude Medical (CardioMEMS) MARCS-CMS 480398 —

Recipient Name
Mr. Heerain Piplani
Recipient Title
Operations Director
St. Jude Medical (CardioMEMS)

387 Technology Circle NW
Suite 500
Atlanta, GA 30313
United States

Issuing Office:
Office of Medical Device and Radiological Health Division 2 - Central

United States

(407) 475-4700

Dear Mr. Piplani:

The Food and Drug Administration has completed an evaluation of your ftrm's corrective actions in response to our Warning Letter [15-ATL-13 dated September 30, 2015]. Based on our evaluation, it appears that you have addressed the violation(s) 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.

Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central

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