FDA may subject pacemaker programmers to premarket review

08/5/2011 | MassDevice.com (Boston)

The FDA has issued a proposed rule that would categorize pacemaker programmers, external tools designed to modify the electrical performance of pacemakers, as Class III devices and would subject them to premarket review. The rule follows an FDA guidance requiring pacemakers to undergo premarket evaluation.

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MassDevice.com (Boston)

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