PINNACLE PELVIC FLOOR REPAIR KIT II

PINNACLE PELVIC FLOOR REPAIR KIT II is an FDA 510(k)-cleared medical device (K081048) manufactured by Boston Scientific Corp. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 21, 2008. Regulation: 8.