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Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology

Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation...

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Bibliografiske detaljer
Main Authors: Rome, Benjamin N., Kramer, Daniel B., Kesselheim, Aaron S.
Format: Artigo
Sprog:Inglês
Udgivet: 2014
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4080312/
https://ncbi.nlm.nih.gov/pubmed/24760423
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11886-014-0489-0
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