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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 Terminated
522 Number / Requirement Number PS110132 / PSS001
Date Original Plan Accepted 05/09/2011
Study Name Metal ion levels
Device Name RING UPM TOTAL HIP REPLACEMENT
Root Document Number K864515 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives Aesculap had the distribution rights for the device. These orders (PS110132 and PS110133) were terminated and new orders were issued for the device to Aesculap, Inc (PS130040 and PS130041)




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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