BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)

BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) is an FDA 510(k)-cleared medical device (K962174) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 20, 1996. Regulation: 8.