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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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Metal ion levels


 
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General
Study Status Other
522 Number / Requirement Number PS110105 / PSS001
Date Original Plan Accepted 05/09/2011
Study Name Metal ion levels
Device Name Apr metasul acetabular insert
Root Document Number K993569 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives The manufacturer ceased market distribution of the device subject to the postmarket surveillance order. If manufacturer resumes device distribution they will be required to address the postmarket surveillance order.




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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