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Vol. 2, No. 15 April 11, 2016IN THIS ISSUE World's the smallest pacemaker gets thumbs up from the FDA.......................... Page 3 Medtronic: New tax inversion rules shouldn't have material impact.........
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FDA approves the world's smallest medical device.
Manufacturers of the medical device are required to file for FDA approval.
The manufacturers need to submit an application with all the necessary information and documentation to FDA.
The purpose is to ensure the safety and efficacy of the medical device before it is marketed and used by the public.
Manufacturing process, clinical trials data, safety information, and intended use must be reported.
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