SOBORG, Denmark, April 15 /PRNewswire/ -- Contura Inc. has submitted a Premarket Approval Application (PMA) for Aquamid(R) to the U.S. Food and Drug Administration (FDA) requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.
If approved for the U.S. market, Aquamid will be produced at Contura's new manufacturing facility in Denmark, which was designed to meet FDA requirements, and was recently approved by the European authorities.
Contura is a medical technology company based in Denmark that develops, manufactures, and commercializes soft tissue fillers in compliance with the European regulatory requirements for medical devices. Contura's products -- Aquamid for facial contouring and Bulkamid(R) for the treatment of female urinary incontinence -- are manufactured using the company's patented polyacrylamide hydrogel technology. Aquamid is sold through a network of local distributors in several countries in Europe, Asia, the Middle East and Latin America. Ethicon Inc., a Johnson & Johnson company, holds the exclusive worldwide distribution rights for Bulkamid.
CONTACT: Susan Smirnoff, Ruder Finn, +1-212-593-6323,
Web site: http://www.contura.com/