Spectranetics Corporation MARCS-CMS 491979 —
- Medical Devices
Recipient NameChristopher Barys
Recipient TitleBusiness Leader
- Spectranetics Corporation
- Philips Image Guided Therapy Devices
3721 Valley Centre Sr.
San Diego, CA 92130
- Issuing Office:
- Center for Devices and Radiological Health
Irvine, CA 92612
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.
Jeffrey R. Wooley
Director of Compliance Branch
Office of Medical Device and Radiological Health
Ms. Lindsay Pack
9965 Federal Dr.
Colorado Springs, CO 80921