ABD and its predecessors have been registered with and inspected by the US Food & Drug Administration since 1976. Our original diaphragm pacing 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 Diaphragm Pacing System System is the only device with such approval.
The premarket approval number for the Diaphragm Pacing System 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 EC Declaration of Conformity is based on approved quality system and design examination by the Notified Body BSI Management Systems.
The Avery Diaphragm Pacing System System has been registered with the Administractión Nacional de Medicamentos Alimentos y Tecnologia Médica since June 2010.
The Avery Diaphragm Pacing System System has been registered with the Brazilian Ministry of Health since December 2009.