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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Ext FU Premkt Cohort Inspire 4 STAR Trial

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Study Status Progress Adequate
Application Number P130008 / PAS001
Date Current Protocol Accepted 04/30/2014
Study Name OSB Lead-Ext FU Premkt Cohort Inspire 4 STAR Trial
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description to demonstrate long-term safety - Prospective, single arm cohort study
Study Population Description Subjects implanted with the Inspire UAS System under the premarket study.
Sample Size Approximately 124 STAR trial subjects are available for the

extended follow-up

Data Collection Long term safety of the Inspire system will be assessed via the description of all reported adverse events. Adverse events captured in the premarket study will be summarized by seriousness, severity, relatedness to the device and temporal relationship to the procedure, annually.
Follow-up Visits and Length of Follow-up 5 years post-implant

OSB Lead-Ext FU Premkt Cohort Inspire 4 STAR Trial Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 04/30/2015 05/04/2015 Overdue/Received
two year report 04/29/2016 04/29/2016 On Time
Final Report 06/29/2017 06/29/2017 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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