FDA Cites Medtronic, Inc. for Misleading Spine Surgeons

WASHINGTON (Reuters) - 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.”

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