Zdrowie i gospodarka · 22/06/2012
FDA Mandates Premarket Approval for Implantable Pacemaker Pulse Generators
The US Food and Drug Administration (FDA) is requiring manufacturers to submit premarket approval applications or product development protocol notices for implantable pacemaker pulse generators, aiming to reduce the risk of illness or injury associated with these devices.
Source: Federal Register — Food and Drug AdministrationOpen original release →