Regulatory Approvals

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.

The premarket approval number for the Mark IV 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.

Avery Biomedical Devices holds certificate number FM 547851 and operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for the design and development, production and servicing of implanted diaphragm pacemaker systems.

The quality management system of ABD is certified in compliance with CAN/CSA ISO13485:1998 which is a requirement for distribution in Canada. Breathing pacemakers are not currently licensed by Health Canada for sale or distribution within Canada. However, breathing pacemakers are available to Canadian patients through the Health Canada Special Access Programme.