• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

  • Print
  • Share
  • E-mail
-
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.

Learn more...

            
  To search for Manufacturer beginning with a specific letter, select that letter
 
 A 
 B 
 C 
 D 
 E 
 F 
 G 
 H 
 I 
 J 
 L 
 M 
 N 
 O 
 P 
 R 
 S 
 T 
 U 
 V 
 W 
 X 
 Z 
 
 
   

Metal ion levels


 
Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Terminated
522 Number / Requirement Number PS110094 / PSS001
Date Original Plan Accepted 05/09/2011
Study Name Metal ion levels
Device Name Rs-cup acetabular prosthesis
Root Document Number K885049 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives The postmarket surveillance (522) order was terminated because the device was not cleared to use with MoM systems. Therefore, the postmarket surveillance order does not apply.




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


-
-