mHealth Alert: FCC Extends Boston Scientific's Authority for Implanted Cardiac Devices

The Federal Communications Commission (FCC) recently granted a rule waiver requested by Boston Scientific Corporation (Boston Scientific), allowing it to continue to manufacture and market its Contak Renewal TR product line of implanted cardiac medical devices. The rule waiver remains valid until May 8, 2011 or 90 days after the date on which the Food and Drug Administration (FDA) approves Boston Scientific’s replacement for the Contak Renewal TR devices (the Cognis CRT-P product line), whichever comes earlier.

Please see full alert for more information.

LOADING PDF: If there are any problems, click here to download the file.