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Spectranetics Corporation MARCS-CMS 491979 —

Medical Devices

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.

Jeffrey R. Wooley
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West

Ms. Lindsay Pack
Spectranetics Corporation
9965 Federal Dr.
Colorado Springs, CO 80921

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