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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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PSS


 
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General
Study Status Terminated
522 Number / Requirement Number PS130045 / PSS001
Date Original Plan Accepted 07/29/2013
Study Name PSS
Device Name Modular range of ring pros. For hip replacement
Root Document Number K083651 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives Postmarket surveillance (522) order is no relevant to this device. Manufacturing discontinued in the 1980s




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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