Wednesday, October 10, 2007

Medtronic in the news again

From the article:
Medtronic Inc. was warned by the U.S. Food and Drug Administration that a manual for the company's Satellite spinal device encouraged its use in unapproved ways.

The device is intended to be fused with a bone graft to stabilize and hold together parts of the vertebrae while they heal, the FDA said in a warning letter posted today on the agency's Web site. Medtronic's surgical technique manual described a non-fusion procedure without implantation of a bone graft, according to the letter, dated Oct. 1.

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