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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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Athena PAS


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General
Study Status Ongoing
Application Number /
Requirement Number
P030053 S069/ PAS001
Date Original Protocol Accepted 01/17/2025
Date Current Protocol Accepted  
Study Name Athena PAS
Device Name MemoryGel® Ultra High Profile - Extended Range (UH-R) Breast Implants
Clinical Trial Number(s) NCT02724371  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


Athena PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/23/2025    
1 year report 11/22/2025    
2 year report 11/22/2026    
3 year report 11/22/2027    
4 year report 11/21/2028    
5 year report 11/21/2029    


Contact Us

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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