St. Jude Medical (CardioMEMS)

CLOSEOUT LETTER St. Jude Medical (CardioMEMS) MARCS-CMS 480398 — October 17, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: 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. Sincerely, /S/ Blake Bevill, M.S. Program Division Director Office of Medical Device and Radiological Health Division 2 - Central Content current as of: 11/25/2020