BioCentury
ARTICLE | Clinical News

FocalSeal-L synthetic absorbable surgical sealant regulatory update

May 15, 2000 7:00 AM UTC

The FDA's General and Plastic Surgery Devices Advisory Panel unanimously recommended approval of FocalSeal-L for use in sealing air leaks following lung surgery. The recommendation states that product labeling should include warning of higher rates of wound infections and empyema and additional long-term data on tumor growth. FOCL completed its PMA submission for the product last June. ...