MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS is an FDA 510(k)-cleared medical device (K896443) manufactured by Possis Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 19, 1989. Regulation: 8.