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FDA Warns Medtronic

We’re just hearing about a May 7, 2010 FDA warning letter to Medtronic over Medtronic’s failure to establish protocols to review customer complaints and to validate device designs. The letter relates to image-guided surgical systems for spinal, cranial, and ENT applications.
This probably isn’t a huge deal, and doesn’t imply any particular defects. On the other hand, it’s hard to know about defects if Medtronic isn’t actively looking for them…

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