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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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Indego Postmarket Surveillance Study

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Study Status Progress Inadequate
522 Number / Requirement Number PS160003 / PSS001
Date Current Plan Accepted 10/07/2016
Study Name Indego Postmarket Surveillance Study
Root Document Number K152416 
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Indego Postmarket Surveillance Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 04/07/2017 04/03/2017 On Time
1 year report 10/07/2017 10/03/2017 On Time
18 month report 04/07/2018 04/05/2018 On Time
2 year report 10/07/2018 10/03/2018 On Time
3 year report 10/07/2019 10/03/2019 On Time
4 year report 10/06/2020 10/05/2020 On Time
5 year report 10/06/2021