ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP is an FDA 510(k)-cleared medical device (K090713) manufactured by American Medical Systems, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 1, 2009. Regulation: 8.