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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Inspire UAS New Enrollment PAS

General
Study Status	Delayed
Application Number / Requirement Number	P130008 S089/ PAS001
Date Original Protocol Accepted	05/19/2023
Date Current Protocol Accepted	10/22/2025
Study Name	Inspire UAS New Enrollment PAS
Device Name	Inspire Upper Airway Stimulation
Clinical Trial Number(s)	NCT02344108
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	Sponsor Registry
Comparison Group	Device Subjects Serve as Own Control
Analysis Type	Descriptive
Study Population	Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Objectives	This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA). Subjects will be followed for five (5) years post-implant. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
Study Population	Study Population Patients with Severe OSA with Down syndrome who are implanted with Inspire UAS Prospective Participants: In Lab PSG annually. Roll-over participants: Any data reported as an interim data in IDE 200322 will be utilized in the study.
Sample Size	Number of subjects: 60
Key Study Endpoints	Endpoints Safety : device and procedure related events Effectiveness: AHI change ODI Change Change ESS-CHAD
Follow-up Visits and Length of Follow-up	Follow-up Prospective participants will be enrolled in the study prior to implant. Data for each implanted subject will be collected at the following timepoints: • Baseline • Implant • 1 Week Post-op • Activation (1 Month Post-Implant) • 2 Months Post-Implant • 3 Months Post-Implant • 4 Months Post-Implant • 6 Months Post-Implant • 1, 2, 3, 4, 5 Years Post-Implant • Interim Visits (if applicable) Roll-over Participants will undergo prospective study visits depending on the timing of their enrollment into this post-approval study and the length of time since they’ve been implanted with the Inspire System. Baseline, Implant and follow-up data through 1 year will be rolled over from the IDE (G200322) study. Retrospective data will be collected (as available) from the time of study exit (from IDE G200322) until enrollment into this PAS. Once the patient is enrolled into the PAS, prospective study visits will begin according to where the patient is at in the visit schedule.

Inspire UAS New Enrollment PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	09/18/2023	09/22/2023	Overdue/Received
1 year report	03/19/2024	03/15/2024	On Time
18 month report	09/17/2024	09/13/2024	On Time
2 year report	03/19/2025	03/17/2025	On Time
3 year report	03/19/2026
4 year report	03/19/2027
5 year report	03/19/2028
final report	10/19/2030

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