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Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices
OBJECTIVE: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. DESIGN: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to st...
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| Main Authors: | , , , , |
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| 格式: | Artigo |
| 語言: | Inglês |
| 出版: |
Bentham Science Publishers Ltd.
2008
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| 主題: | |
| 在線閱讀: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2577946/ https://ncbi.nlm.nih.gov/pubmed/19088864 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2174/1874312900802010007 |
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