Zdrowie i gospodarka · 27/07/2011

Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

The Food and Drug Administration (FDA) is proposing to require premarket approval for an implantable pacemaker pulse generator, a class III device, by submitting a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP). The FDA aims to reduce the risk of illness or injury associated with the device and to ensure public benefits from its use.