BIOPATCH BOVINE PERICARDIAL PATCH

BIOPATCH BOVINE PERICARDIAL PATCH is an FDA 510(k)-cleared medical device (K840756) manufactured by Meadox Medicals, Div. Boston Scientific Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 1985. Regulation: 8.