FDA warns medical device maker Medtronic to correct violations

Posted by Sarah Showard | Sep 14, 2012 | 0 Comments


The U.S. Food and Drug Administration sent a warning letter to medical device maker Medtronic, saying it lacks adequate complaint procedures and its response to complaints and an FDA investigation were inadequate. Medtronic manufactures implantable drug infusion systems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoring products and other neurological medical/surgical products.

The devices in question are intended to deliver drugs and stimulation to the brain and spinal cord, similar to how cardiac pacemakers work, to treat a variety of ailments including Parkinson's disease and chronic pain.

The FDA told Medtronic in a letter dated July 17, 2012, that regulatory action might ensue should the manufacturer fail to address the agency's request to take action. The FDA also told the company that it will not approve any device in question unless Medronic addresses its concerns properly.

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About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Women's Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorney, and has been representing plaintiffs since 1990. Sarah has a son, Benjamin, who recently graduated from The Gregory School and will attend ASU in the fall, with future plans to attend law school and eventually join Showard Law Firm. In her spare time Sarah enjoys horseback riding and spending time in Sonoita with her husband Peter.


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