Zdrowie i gospodarka · 06/07/2012

FDA Issues Final Rule Requiring Premarket Approval for Cardiovascular Pacemaker Electrode

The US Food and Drug Administration (FDA) is mandating that manufacturers submit a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for cardiovascular permanent pacemaker electrodes, aiming to reduce the risk of illness or injury associated with the device.