This article was originally published in The Gray Sheet
Executive SummaryResponds to FDA's request for more data to support the company's premarket approval application for VasoSeal, a device for facilitating hemostasis following angioplasty and angiography. Datascope altered its PMA to seek approval only for the angiography indication in September 1993; the latest data submission, the company says, contains clinical data in support of the angioplasty indication ("The Gray Sheet" July 11, In Brief)
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