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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Greenfield PS study

General
Study Status	Completed
522 Number / Requirement Number	PS130002 / PSS001
Date Original Plan Accepted	03/15/2013
Study Name	Greenfield PS study
Device Name	Vena cava filters
Root Document Number	K901659  K870729  K852097  K901235
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives	The Sponsor appealed the 522 order and provided additional data to the Center. It was decided by the Center that the data provided adequately addressed the order.
Interim or Final Data Summary
Final Safety Findings	The Sponsor appealed the 522 order and provided additional data to the Center. It was decided by the Center that the data provided adequatly addressed the order.

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