Spectranetics Corporation

CLOSEOUT LETTER Spectranetics Corporation MARCS-CMS 491979 — May 16, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Christopher Barys Recipient Title Business Leader Spectranetics Corporation Philips Image Guided Therapy Devices 3721 Valley Centre Sr. Ste. 500 San Diego , CA 92130 United States Issuing Office: Center for Devices and Radiological Health 19701 Fairchild Irvine , CA 92612 United States Dear Mr. Barys: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [DEN-16-08-WL dated May 23, 2016]. 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/ Jeffrey R. Wooley Director of Compliance Branch Office of Medical Device and Radiological Health Division 3/West cc: Ms. Lindsay Pack Spectranetics Corporation 9965 Federal Dr. Colorado Springs, CO 80921 Content current as of: 05/21/2019 Regulated Product(s) Medical Devices