Prostar PMA approval supported by independent Harvard analysis, Perclose says.
This article was originally published in The Gray Sheet
Executive Summary
PERCLOSE PROSTAR PMA APPROVAL SUPPORTED BY HARVARD DATA CENTER ANALYSIS, the firm says in an Aug. 28 press release. The one-paragraph statement responds to competitor Datascope's Aug. 6 citizen's petition to FDA seeking revocation of a premarket approval application for the suture-based system for arterial access site closure. Perclose says it does not plan to submit a detailed response to the Datascope petition because it believes its PMA stands on its own merits.