Resources for Food and Drug Administration (FDA)

FDA cites Medtronic for misleading spine surgeons

www.reuters.com

U.S. drug regulators admonished Medtronic Inc for marketing unapproved uses for a spine product in an instruction manual for surgeons, according to a letter released on Tuesday.

The U.S. Food and Drug Administration in a warning letter dated October 1 told the medical device maker that the surgical technique manual describes use of the system "that could significantly affect its safety and effectiveness."

The so-called Satellite Spinal System is composed of spheres inserted between vertebras to stabilize the spine.

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