TYRX Inc.

CLOSEOUT LETTER TYRX Inc. MARCS-CMS 497549 — April 17, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 16-NWJ-08 Product: Medical Devices Recipient: Recipient Name Omar S. Ishrak Recipient Title Chief Executive Officer TYRX Inc. 710 Medtronic Parkway Minneapolis , MN 55432 United States omar.ishrak@medtronic.com 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 16-NWJ-08 CMS # 497549. 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/ Demetria L. Lueneburg Compliance Officer Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2 – Central Content current as of: 04/27/2020 Regulated Product(s) Medical Devices