Endologix PowerLink
This article was originally published in The Gray Sheet
Executive Summary
Firm will respond within five weeks to an FDA letter requesting further information on the abdominal aortic aneurysm stent graft PMA application, the company reports May 4. The letter requests further data analysis, but does not seek additional data or include any Form 483 inspection observations from FDA's quality and clinical inspections of EndoLogix' Irvine, Calif. facility. An advisory panel review of the PMA may be required...