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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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Belotero Balance PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P090016 / PAS003
Date Original Protocol Accepted 05/01/2012
Date Current Protocol Accepted 05/01/2012
Study Name Belotero Balance PAS
Device Name BELOTERO BALANCE
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 117 adults
Actual Number of Sites Enrolled 9
Patient Follow-up Rate 97% (113/117)
Final Safety Findings Re-treatment with Belotero Balance did not result in an increase in ¿severe¿ adverse events (AEs). Total percentage subjects with severe ¿common¿ AEs was 15.6% after the initial treatment, during the pre-approval study, and 7.7% with re-treatment during the post-approval study (p<0.0085). Specifically, the incidence rates of severe adverse events after re-treatment were 11.5% and 5.4% for subjects with Fitzpatrick Skin Type Grades I-III and Grades IV-VI respectively. The duration of ¿severe¿ adverse events with re-treatment was generally short (mean 10.2 days, SD = 5.6, 95% CI = 8.2, 12.2) and none of these events required treatment.
Final Effect Findings No effectiveness endpoints were included in the study.
Study Strengths & Weaknesses The post-approval study sample size was 117 exceeding the minimum requirement of 104 subjects. A total of 113 re-treated subjects completed the study achieving a 97% follow-up rate. Adverse events occurring beyond one month after re-treatment were not captured because the length of follow-up was restricted to one month.
Recommendations for Labeling Changes Labeling changes are recommended to reflect severe adverse event incidence rates after re- treatment.


Belotero Balance PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/14/2012 06/18/2012 Overdue/Received
one year report 11/13/2012 11/06/2012 On Time
18-month report-FINAL REPORT 05/14/2013 03/18/2013 On Time


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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