EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS is an FDA 510(k)-cleared medical device (K083499) manufactured by Coloplast A/S. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on May 7, 2009. Regulation: 8.