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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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  To search for Manufacturer beginning with a specific letter, select that letter

Bateman Bottle Postmarket Surveillance Study

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Study Status Noncompliant
522 Number / Requirement Number PS230003 / PSS001
Study Name Bateman Bottle Postmarket Surveillance Study
Device Name The bateman bottle
Root Document Number DEN220082 
General Study Protocol Parameters
Study Population

Bateman Bottle Postmarket Surveillance Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/20/2023    
1 year report 06/20/2024    
18 month report 12/19/2024    
2 year report 06/20/2025    
3 year report 06/20/2026