A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE

A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE is an FDA 510(k)-cleared medical device (K970388) manufactured by Biotronik, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 1997. Regulation: 8.