PINNACLE PELVIC FLOOR REPAIR KITS

PINNACLE PELVIC FLOOR REPAIR KITS is an FDA 510(k)-cleared medical device (K071957) 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 November 7, 2007. Regulation: 8.