SynCardia Systems LLC

CLOSEOUT LETTER SynCardia Systems LLC MARCS-CMS 537226 — June 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Medical Devices Recipient: Recipient Name Don Webber Recipient Title Chief Operating Officer SynCardia Systems LLC 1992 East Silverlake Road Tucson , AZ 85713 United States Issuing Office: Center for Devices and Radiological Health 19701 Fairchild Road Los Angeles , CA 92612 United States Dear Mr. Webber, The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #537226), dated 04/03/2018. 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/ Bryan Love Acting Compliance Branch Director Division 3/West Office of Medical Device and Radiological Health Operations Content current as of: 07/18/2019 Regulated Product(s) Medical Devices