LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD is an FDA 510(k)-cleared medical device (K894494) manufactured by Biotronik, GmbH & Co.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 16, 1989. Regulation: 8.