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.

	FDA Premarket Approval Letter. Adobe Reader is required to view PDF files.

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.

D.M. Gore, Ph.D.
Dan-y-Mur, Llanover, Abergavenny
NP7 9EY Monmouthshire, UNITED KINGDOM
ec-rep@averybiomedical.com

	ISO-13485 Certificate. Adobe Reader is required to view PDF files.
	EC Design Examination Certificate. Adobe Reader is required to view PDF files.
	EC Quality Assurance Certificate. Adobe Reader is required to view PDF files.

ABD and its Breathing Pacemaker System have been registered with the Russian Ministry of Health since May 2010.

	Roszdravnadzor Certificate. Adobe Reader is required to view PDF files.