ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION is an FDA 510(k)-cleared medical device (K121612) manufactured by American Medical Systems. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on July 19, 2012. Regulation: 8.