EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM is an FDA 510(k)-cleared medical device (K112386) manufactured by Coloplast Corp.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 7, 2011. Regulation: 8.