Regulatory Approvals

United States

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 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.

  FDA Premarket Approval Letter


Colombia

The Avery Breathing Pacemaker System has been registered with Instituto Nacional de Vigilancia de Medicamentos y Alimentos since February 2009.

Our authorized representative in Colombia is Medihumana Colombia.

  INVIMA Certificate


Argentina

The Avery Breathing Pacemaker System has been registered with the Administractión Nacional de Medicamentos Alimentos y Tecnologia Médica since June 2010.

  ANMAT Certificate.


European Community

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.

  BSI Registration Certificate

  EC Design Examination Certificate

  EC Quality Assurance Certificate


Russian Federation

The Avery Breathing Pacemaker System has been registered with the Russian Ministry of Health since May 2010.

Our authorized representative in the Russian Federation is Edward Indilov.

  Roszdravnadzor Certificate


Brazil

The Avery Breathing Pacemaker System has been registered with the Brazilian Ministry of Health since December 2009.

  Diário Oficial da Uniâo