Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
Firm submits amendment to a premarket approval application for its Intergel adhesion prevention barrier that responds to "all questions raised" by FDA's General and Plastic Surgery Devices Advisory Panel in January (1"The Gray Sheet" Jan. 17, p. 4). The panel cited higher than expected infection rates and deficiencies in the statistical analysis conducted by the company among the reasons FDA should not approve the firm's PMA