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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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TherOx PAS


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General
Study Status Study Pending
Application Number /
Requirement Number		 P170027 / PAS002
Date Original Protocol Accepted 04/10/2026
Date Current Protocol Accepted 04/10/2026
Study Name TherOx PAS
Device Name TherOx Downstream System
Clinical Trial Number(s) NCT02603835 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit.Adolescent B(as adults): 18 yrs < 22 yrs
Detailed Study Protocol Parameters
Study Objectives This study is an observational, prospective analysis of subjects undergoing primary PCI for AMI and receiving SSO2 Therapy delivered by the TherOx DownStream System or standard of care (PCI only). This study is not blinded. It is open label, both to the treating physician and the subject.
Study Population The study will prospectively enroll up to 1,125 subjects across three cohorts from up to 40 sites (maximum 10 sites outside the US): 500 control subjects, 500 subjects who received SSO2 Therapy per product label, and up to 125 subjects who received SSO2 Therapy off-label based on clinician judgment for the subject's best interest.
Sample Size 1,125 subjects
Key Study Endpoints There are two co-primary endpoints. The first co-primary composite endpoint is CV death or HF event at the median timepoint of 1.5 years, and the second co-primary endpoint is infarct size.
Follow-up Visits and Length of Follow-up 24 months


TherOx PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/10/2027    
18 month report 10/10/2027    
2 year report 04/10/2028    


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

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