Perclose must file premarket approval (PMA) for vessel closure devices:
This article was originally published in Clinica
Executive Summary
Perclose has been told it will have to file a PMA for its Prostar vascular closure devices, but that it will receive an expedited review. The company had previously submitted a 510(k) premarket clearance notification based on a 500-patient multicentre trial of the 9- and 11-F Prostar devices, which are used to close arteries catheterised during angioplasty. Perclose says it will use the same data for the PMA.