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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Chemical/Physical Evaluation

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Application Number P090016 / PAS001
Current Plan Approved 12/07/2012
Study Name Chemical/Physical Evaluation
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Bench/Lab study to evaluate the chemical/physical reasons that the injection force of Belotero Balance decreases as a function of time during product storage.
Study Population Description Not applicable. This is a bench/lab study.
Sample Size Not applicable. This is a bench/lab study.
Data Collection Not applicable. This is a bench/lab study.
Follow-up Visits and Length of Follow-up Not applicable. This is a bench/lab study.
Final Study Results
Number of Patients n/a - bench study
Number of Sites n/a - bench study - actual number of batches studied: 3
Follow-up Rate The ejection force of three device¿s batches was evaluated in the laboratory during 24 months.
Safety Findings ¿ Over 24 months at room temperature, the ejection force and dynamic viscosity of the product decrease, but remain within the previously set specifications. From a clinical perspective, then, the material is suitable for a 24 month shelf life.

¿ Because only soluble hyaluronic acid (HA) that is a listed ingredient and not a proprietary ingredient was evaluated and not the crosslinked portion, and because the nature of the soluble HA was variable from time point to time point, it is difficult to draw correlations between the viscosity of the material and the network structure/molecular weight distribution of the product. Generally speaking, physical properties arise from chemical characteristics. In this case, there are multiple factors, chiefly the distribution and degradation of the soluble HA component (and secondarily the apparent burst release of soluble HA), that may ultimately lead to the decrease

in material properties.

Strengths & Weaknesses A. Strengths:

¿The evaluation procedures carried out in this study effectively tested stability and ejection force parameters for this device.

¿The study approach was adequate to reveal the behavior and properties of this device at up to 24 months shelf life.

¿The methodology used in this study could be helpful in the evaluation of this class of devices.

B. Limitations

¿The methodology used was limited in scope to evaluate soluble HA that is a listed ingredient and not a proprietary ingredient.

Label Changes no (No unexpected findings were reported and no additional information from the PAS is needed in the labeling).

Chemical/Physical Evaluation Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 05/14/2012 07/31/2012 Overdue/Received
one year report 11/13/2012 11/07/2012 On Time
18 month report 05/14/2013 05/14/2013 On Time
two year report 11/13/2013 11/07/2013 On Time
three year report-final report 11/13/2014 11/12/2014 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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