Plastic Surgery Devices Panel of FDA to Vote on Cyanoacrylate Tissue Adhesive

Plastic Surgery Devices Panel of The Food and Drug Administration (FDA) meets tomorrow to Vote on Cyanoacrylate Tissue Adhesive

On August 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: cyanoacrylate tissue adhesive. Background information for this meeting, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at the following link “Upcoming CDRH Advisory Panel/Committee Meetings. Material for the August 24 and 25 sessions will be posted on August 23, 2006.

David Krause
Center for Devices and Radiological Health (HFZ-410)
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
301-594-3090, ext. 141
or FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC area)
code 3014512519. Please call the Information Line for up-to-date information on this meeting.

Briefing Information for August 24th Meeting