FDA docs lodged in May. Decision within 90 days, 5 August, but a...

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    FDA docs lodged in May. Decision within 90 days, 5 August, but a 6 to 8 week extension as the FDA had a follow-up question. So, with any luck, a FDA decision any day now. What would be even better is an FDA approval any day now . This timeline is only for the valve testing not the heart failure testing but the company claims FDA approval for either or is a company maker.
 
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