Stat Medical Devices, Inc.

CLOSEOUT LETTER Stat Medical Devices, Inc. MARCS-CMS 473754 — March 28, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Stat Medical Devices, Inc. United States Issuing Office: United States 555 Winderley Place #200 Maitland, FL 32751 Telephone: (407) 475-4700 VIA ELECTRONIC MAIL sschraga@statdevices.com March 28, 2018 Mr. Steven Schraga, President Stat Medical Devices, Inc. 2056 NE 153rd Street Miami, FL 33162 U.S.A. RE: Warning Letter Close-Out Letter – FEI 1000525253 CMS Case ID: 473754, CMS WA ID: 144791 Dear Mr. Schraga: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-15-29, dated July 23, 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/ Rafael Padilla Acting Program Division Director Division of Medical Devices and Radiological Health Operations II Central Content current as of: 03/29/2018