The FDA is not comfortable with the 510-K application otherwise they would have approved the device by now. There is something that rally bothers them. Dean has not managed after 3+ years to rectify this situation with resubmittle after resubmittle. Yes I agree that Dean can resubmit forever but in the meantime he FDA will push him out of the 510-K process. PMA as a FDA response/strategy fits.
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