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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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BSI rate


 
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General
Study Status Completed
522 Number / Requirement Number PS100009 / PSS001
Date Original Plan Accepted 09/09/2011
Date Current Plan Accepted 09/09/2011
Study Name BSI rate
Device Name Maxplus tru-swab positive displacement connector
Root Document Number K051939 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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 522 order and provided additional data from literature that was determined adequte to address the 522 questions.




Contact Us


Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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