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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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OSB Lead-VOLUMA-003 Repeat Treatment Study


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General
Application Number P110033 / PAS001
Current Plan Approved 10/22/2013
Study Name OSB Lead-VOLUMA-003 Repeat Treatment Study
General Study Protocol Parameters
Study Design Other Study Design
Data Source Other Data Source
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Statistical analysis of data collected in the premarket study
Study Population Description Subjects who enrolled in the premarket study and received repeat treatment
Sample Size At least 167 modified intent-to-treat (mITT) subjects.
Data Collection Safety Endpoints include: presence, severity, location (zygomaticomalar region, anteromedial cheek, and/or

submalar region), and duration of common treatment site responses (CTRs) and any adverse events (AEs) after repeat treatment. There are no effectiveness endpoints.

Follow-up Visits and Length of Follow-up 12 months after repeat treatment

1, 3, 6, 9, and 12 months after repeat treatment



OSB Lead-VOLUMA-003 Repeat Treatment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/22/2014 04/18/2014 On Time
one year report-final report 10/22/2014 09/29/2014 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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