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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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AE and effectiveness rates

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Study Status Other
522 Number / Requirement Number PS120094 / PSS001
Date Current Plan Accepted 03/05/2013
Study Name AE and effectiveness rates
Root Document Number K092607 
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population All Pediatric Patients: 0-21 yrs
Detailed Study Protocol Parameters
Study Design Description 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.