FDA might lower risk classification for 3 heart devices

09/13/2013 | MassDevice.com (Boston)

An FDA panel has proposed that the agency downgrade external pacemaker pulse generators, triple-chamber pacing system analyzers and external cardiac compressors from Class III to Class II medical devices. If the FDA approves the proposal, the devices would be subjected to the 510(k) clearance process, instead of the more stringent premarket approval program.

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MassDevice.com (Boston)

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