522 Postmarket Surveillance Studies Database

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

General
Study Status	Terminated
522 Number / Requirement Number	PS110133 / PSS001
Date Original Plan Accepted	05/09/2011
Study Name	Metal ion levels
Device Name	MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
Root Document Number	K871956
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

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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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• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry and Food and Drug Administration Staff
• 522 Program Background