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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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VasQ Postmarket Surveillance Study


 
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General
Study Status Plan Pending
522 Number / Requirement Number PS230004 / PSS001
Study Name VasQ Postmarket Surveillance Study
Device Name Vasq
Root Document Number DEN220026 
General Study Protocol Parameters
Study Population


VasQ Postmarket Surveillance Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/27/2024    
1 year report 09/26/2024    
18 month report 03/27/2025    
2 year report 09/26/2025    
3 year report 09/26/2026    
4 year report 09/26/2027    


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