The first review team did not approve the device because they had concerns. All this information was in the file when the new review team took over. Are you saying that two years of FDA review had no affect on the final outcome and the overall length of the approval process? It definitely would have shortened the response time of the new reviewer. After reading the file the new review team had the same concerns. The radiologist report that they requested was their response in seeking clarification of these concerns. Either the material that Dean submitted to them was inadequate or it does not address the problem.
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