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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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TMJM Registry Study - Partial


 
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General
Study Status Redesigned/Replaced Study
522 Number / Requirement Number PS110002 / PSS004
Date Original Plan Accepted 03/16/2016
Study Name TMJM Registry Study - Partial
Device Name Tmj fossa-eminence/condylar prosthesis system
Root Document Number P000023  P000035 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21




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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