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How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
BACKGROUND: The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review track...
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| Publicado no: | Clin Orthop Relat Res |
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| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer US
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4773325/ https://ncbi.nlm.nih.gov/pubmed/26584802 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11999-015-4634-x |
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