CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA

CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA is an FDA 510(k)-cleared medical device (K853294) manufactured by Cardiac Control Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 3, 1985. Regulation: 8.