CDRH APPROVES PMA FOR HISTOACRYL SKIN ADHESIVE

CDRH recently approved the premarket approval (PMA) application for Histoacryl and Histoacryl Blue Topical Skin Adhesive.

The device is indicated for topical application to close easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl and Histoacryl Blue Topical Skin Adhesive may be used with, but not instead of, dermal sutures, the agency said.

Histoacryl and Histoacryl Blue are sterile liquid topical skin adhesives. The two products differ in that Histoacryl is a colorless liquid while Histoacryl Blue is colored with dye for ease of viewing during application. Both products retain liquid form until exposed to water or water-containing substances/tissue, after which they cure (polymerize) and form a film that bonds to the surface.

B. Braun has marketed Histoacryl outside the U.S. since 1979.