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 PMA supplement approved in November 2019. FDA premarket approval is required before Class III medical devices can be commercially distributed in the United States. The Avery Diaphragm Pacing System is the only device with full FDA PMA approval for adults & pediatrics.
The premarket approval number for the Diaphragm Pacing System is P860026. The FDA Center for Devices and Radiological Health has assigned diaphragmatic/phrenic nerve stimulators the product code GZE under CFR 882.5830.
The Avery Diaphragm Pacing System has been registered with the Administractión Nacional de Medicamentos Alimentos y Tecnologia Médica since June 2010.
The Avery Diaphragm Pacing System has been registered with Instituto Nacional de Vigilancia de Medicamentos y Alimentos since February 2009.
Our authorized representative in Colombia is Medihumana Colombia.
Avery Biomedical Devices holds certificate number FM 547851 and operates a Quality Management System which complies with the requirements of ISO 13485: 2016 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 EU Authorized Representative is Advena Ltd.
Notified Body Confirmation Letter Regulation EU 2023/607 amending EU MDR 2017/745 Extended Transitional Provisions
EU MDR 2017/745 – Manufacturer’s Declaration for Extended Transitional Provisions
EC Design Examination Certificate
BSI Registration Certificate
EC Quality Assurance Certificate
Advena Ltd. Certificate of Designation
The Avery Diaphragm Pacing System has been registered with the Israel Ministry of Health – Medical Technology, Information and Research Division (Medical Devices Department).
Our authorized representative is Lowenstein-Weinmann Medical Israel Ltd.
אישור הגשה לחידוש Avery
31.01.19 Existing Approval, Avery Biomedical Devices
אישור אמר Avery 31.10.2028
The Avery Diaphragm Pacing System has been registered with the Russian Ministry of Health since May 2010.
Our authorized representative in the Russian Federation is Edward Indilov.
The Avery Diaphragm Pacing System is registered with the UK Medicines & Healthcare products Regulatory Agency (MHRA). The UK Responsible Person (UKRP) is Advena Ltd.
MHRA Registration
MHRA – EU MDR Article 120 Extension Confirmation
Advena Ltd. UKRP Letter of Designation