ABD and its predecessors have been registered with and inspected by the US Food & Drug Administration since 1976. Our original breathing pacemaker system received premarket approval status from the FDA immediately upon requirement in 1986, with the latest modifications approved in March 2003. FDA premarket approval is required before Class III medical devices can be commercially distributed in the United States. The Avery Breathing Pacemaker System is the only device with such approval.he premarket approval number for the Breathing Pacemaker System is P860026. The FDA Center for Devices and Radiological Health has assigned diaphragmatic/phrenic nerve stimulators the product code 84GZE under CFR 882.5830.In addition to your proprietary designs, we have dozens of cuff and button-style electrode configurations available for rapid deployment.Common variables include contact size, contact spacing, and lead length. A variety of lead terminations, including IS-1 connectors, are available to mate your custom electrode design to commercially available IPGs and external test confiurations. Single and dual-channel radiofrequency transmitters with implantable receivers are optional.