VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM is an FDA 510(k)-cleared medical device (K082640) manufactured by Coloplast Manufacturing Us, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2008. Regulation: 8.