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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Prospective Study Plan


 
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General
Study Status Terminated
522 Number / Requirement Number PS110118 / PSS002
Date Original Plan Accepted 05/09/2011
Study Name Prospective Study Plan
Device Name Zimmer m/l taper hip prosthesis with kinectiv technology system
Root Document Number K081007 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives The manufacturer is using a different study design to address the postmarket surveillance study. See more information under PS110118/PS001- Cross-Sectional Plan.




Contact Us


Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources


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