Pre-Market Approval Application


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Pre-Market Approval Application

An application to FDA for a licence to market a new device in the United States.
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US-based medical technology company Becton, Dickinson and Co (BD) (NYSE: BDX) has submitted a pre-market approval application to the US Food and Drug Administration for the BD Onclarity HPV Assay, its human papillomavirus test, the company said on Tuesday.
a developer of stents designed to treat coronary bifurcation lesions, has filed the final module of its Pre-Market Approval application with the US Food and Drug Administration for the Tryton Side Branch Stent, the company said on Monday.
NYSE: MDT) has submitted a pre-market approval application to the US Food and Drug Administration for the use of its SynchroMed II implantable drug infusion system (including a newly developed catheter) for use with US-based United Therapeutics Corp.