Post-Approval Studies (PAS) Database

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Ext FU of the premarket cohort (DREAM Study)

General
Study Status	Study Pending
Application Number / Requirement Number	P240024 / PAS001
Date Original Protocol Accepted	11/07/2025
Date Current Protocol Accepted	11/07/2025
Study Name	Ext FU of the premarket cohort (DREAM Study)
Device Name	Genio® System 2.1
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Device Subjects Serve as Own Control
Analysis Type	Descriptive
Study Population	Adult: >21

Ext FU of the premarket cohort (DREAM Study) Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	02/06/2026		On Time
1 year report	08/08/2026
2 year report	08/08/2027
3 year report	08/07/2028
4 year report	08/07/2029

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background