I've emailed several times now about their seemingly FALSE statement to the SEC that they received PMA for Deltawave in 2008.There is nothing in the database to prove otherwise at this point...it will be a moot point if they announce 510(k) approval but should be addressed regardless.
"Please be advised that the Company received pre-market approval of its DeltaWave device in June 2008. Therefore, we have amended the above-referenced sentence to state “We will need to obtain PMA approval for any future other products we develop.” "
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