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: Mahomed, Nizar N, Syed, Khalid, Sledge, Clement B., Brennan, Troyen A, Liang, Matthew H
Format: Artigo
Jezik:Inglês
Izdano: Bentham Science Publishers Ltd. 2008
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Article
Online dostop: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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