Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen Lp Prolapse Repair System

K080185 is the FDA 510(k) clearance record for AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM, a class III device, cleared for American Medical Systems, Inc. on 2008-04-10 under FDA product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed). FDA's definition for product code OTP reads: "Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed...". FDA records list 82 510(k) clearances for American Medical Systems, Inc., from 1979-05-14 to 2014-06-20. As of 2026-09-10, FDA records show no recalls naming K080185.