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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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The BREEZE Study - PMCF


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General
Study Status Study Pending
Application Number /
Requirement Number		 P250007 / PAS001
Date Original Protocol Accepted 12/11/2025
Date Current Protocol Accepted 12/11/2025
Study Name The BREEZE Study - PMCF
Device Name Zenflow Spring® Implant and Delivery System
Clinical Trial Number(s) NCT02786290 NCT03577236 NCT03595735 NCT04309695 NCT04987138 
General Study Protocol Parameters


The BREEZE Study - PMCF Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/11/2026    
1 year report 12/11/2026    
2 year report 12/11/2027    
3 year report 12/10/2028    
4 year report 12/10/2029    


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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