The US Food and Drug Administra-tion has tentatively listed Genzyme Corp's premarket approval application for its Seprafilm bioresorbable membrane on the agenda of an advisory committee meeting scheduled for March 25. The PMA will be reviewed by the General and Plastic Surgery Devices Panel.
Seprafilm is designed to reduce postoperative adhesion formation in the abdominal and pelvic cavity. Adhesions can make subsequent surgeries more difficult to perform and more dangerous for the patient, and can create complications that can result in infertility in women, chronic pain and intestinal obstruction.
Genzyme said it expects to receive written confirmation when the FDA announces the meeting date in the Federal Register.
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