In Brief: Perclose
This article was originally published in The Gray Sheet
Perclose: Firm's Prostar 9 Fr and 11 Fr percutaneous vascular surgical systems will be reviewed under the premarket approval application process. Menlo Park, California-based Perclose, which submitted a 510(k) in July for the suture-based products, acknowledged at the time of its submission that there was "no assurance" its devices would ultimately be cleared via 510(k). The PMA will include the same data submitted with the 510(k) -- from a 500-patient, randomized, multicenter study comparing Prostar use to mechanical compression. "Based on a preliminary conversation, the FDA also indicated that it will review the PMA application, when filed, on an expedited basis," Perclose says...
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