MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD

MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD is an FDA 510(k)-cleared medical device (K922972) 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 January 21, 1993. Regulation: 8.