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Re: ~ Blue ~ post# 11382

Friday, 06/22/2012 2:15:15 PM

Friday, June 22, 2012 2:15:15 PM

Post# of 39210
If it's is not the same device used on the first submission

Even subsequent improvements render cases invalid. And scans made that were not part of the clinical trial protocol don't have any use in a PMA submission.

Then they cannot use clinical cases from that submission. To get FDA approval the EXACT SAME MACHINE in the EXACT SAME configuration using the EXACT SAME protocol for the intended use of the approval sought.



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