Highlights that most new CIED models are approved via PMA supplements without new clinical data, emphasizing the critical need for robust post-market surveillance.
Emphasizes need for robust postmarket CIED surveillance; leaves open questions on long-term safety without new premarket data.
Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.
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Rome et al. (2014) studied this question.
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