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Zdrowie i gospodarka · 08/08/2011

FDA Proposes Premarket Approval for Cardiovascular Permanent Pacemaker Electrode

The US Food and Drug Administration (FDA) is requiring manufacturers to submit premarket approval applications or product development protocols for a new class III device: the cardiovascular permanent pacemaker electrode, in an effort to reduce the risk of illness or injury associated with its use.

Source: Federal Register — Health and Human ServicesOpen original release →