MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.

MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. is an FDA 510(k)-cleared medical device (K901535) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on July 2, 1990. Regulation: 8.