510(k) K090934

PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM by American Medical Systems, Inc. — Product Code FTL

K090934 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 2009. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.