If your drug eluting stent is the first drug eluting stent on the market, which ...
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If your drug eluting stent is the first drug eluting stent on the market, which medical device filing to the FDA would be required in order for you to start selling your product: A) 510(k) for product clearance or B) Premarket Approval Application (PMA)? Clearly state your choice of A) or B) and explain why.
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