f Post-Approval Studies (PAS) Database
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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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TEO-PAS-2302


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General
Study Status Study Pending
Application Number /
Requirement Number		 P170002 S026/ PAS001
Date Original Protocol Accepted 12/13/2023
Date Current Protocol Accepted 01/17/2024
Study Name TEO-PAS-2302
Device Name RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA1-M with mepivacaine is non-inferior to RHA1 with lidocaine in terms of injection site pain felt by the subject during injection
Study Population Adults 22 years of age or older; cohort will include at least 10% of Fitzpatrick Skin Types V & VI
Sample Size 20
Key Study Endpoints The primary endpoint is injection site pain during injection into the upper perioral rhytids assessed immediately following injection with RHA1-M with mepivacaine (using a 100 mm VAS) compared to the injection site pain felt during injection into the contralateral upper perioral rhytids assessed immediately following injection(s) with RHA1 with lidocaine.

Safety endpoints: Adverse events; visual assessment, neurological assessment, lip functionality
Follow-up Visits and Length of Follow-up The follow-up will be for 30-65 days


TEO-PAS-2302 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/12/2024 04/12/2024 On Time
1 year report 10/12/2024    
18 month report 04/12/2025    
2 year report 10/12/2025    
3 year report 10/12/2026    
4 year report 10/12/2027    


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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