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Examples
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We've taken into account the FDA questions and intent surrounding the thromboresistant PICC family and are performing some additional testing that will push our 510k submission out until about September, and we're hopeful for U.S. launch around the end of the year or early next year.
unknown title 2011
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Turning to Ports, we're facing the same issues on the antimicrobial PowerPort family as we described with the thromboresistant PICC.
unknown title 2011
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The thromboresistant PICC, there are predicates out there.
unknown title 2011
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First off, it's the thromboresistant PICC that we got some questions on.
unknown title 2011
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On the thromboresistant PICC, we faced that issue.
unknown title 2011
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We also received more questions from FDA on our thromboresistant PICC family, including request for additional bench testing and clinical data that we feel are impractical to perform at this time.
unknown title 2011
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