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FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012
IMPORTANCE: The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, du...
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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/PMC4142419/ https://ncbi.nlm.nih.gov/pubmed/24449317 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2013.284986 |
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