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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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| Main Authors: | , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2014
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| Acesso em linha: | 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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